Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R
Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R (Michigan): general & plastic surgery. Its amount of 98 is below the median of 138 (34th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 35/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 98 · 34th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related MI FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261959 |
| Device | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) |
| Applicant | Stryker Instruments |
| Specialty / panel | General, Plastic Surgery |
| Product code | GEI |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-06-11 |
| Decision date | 2026-09-17 |
| Review time (days) | 98 |
| Third-party review | No |
| Applicant location | Portage, MI, US |
| amount percentile | 34th of 414 (median 138, 0.7x median) |
| Peer records CSV (4 MI records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R
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Unlock Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R + all 4 MI records (CSV)
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-17
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (MI first): SafeAir Electrosurgical Generator with Smoke Evacuation (079 · Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ St · Class II recall Z-0188-2027 · SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R and 4 Michigan peers
- Michigan FDAPulse records like this one: 4
- Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R's amount: 34th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Michigan peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
35 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 98-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
What is the FDAPulse record for Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R in Michigan?
Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) (K261959) by Stryker Instruments was cleared on 2026-09-17 after 98 days of review.
How does Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R compare to other Michigan FDAPulse records?
Its amount of 98 is below the median (34th percentile); smaller records often move faster and face less competition. It is 49 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 35/100 is modest; treat it as background rather than a priority.
Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R | MI | 2026-09-17 |
| TECAR Therapy Device (TC2000, TC2001) (K252288) | CN | 2026-10-13 |
| easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291) | CN | 2026-09-25 |
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 |
Related records
- TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd.
- easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.
- PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.
- Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC
- Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.
- SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd.
- VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC
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- HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC
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- Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) (K261572): 510(k) cleared for Keyue (Hangzhou) Medical Information Technology Co., Ltd.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: General & Plastic Surgery devices
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How to monitor Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R and peer general & plastic surgery records
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