HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC
HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC (Puerto Rico): 510(k) cleared for Ethicon Endo-Surgery, LLC. Its amount of 268 is top-decile (90th percentile of 414 records). Dated 48 days ago, it serves as a historical benchmark. Score 55/100. 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: 268 · 90th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related PR FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254196 |
| Device | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) |
| Applicant | Ethicon Endo-Surgery, LLC |
| Specialty / panel | General, Plastic Surgery |
| Product code | GEI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-23 |
| Decision date | 2026-09-17 |
| Review time (days) | 268 |
| Third-party review | No |
| Applicant location | Guaynabo, PR, US |
| amount percentile | 90th of 414 (median 138, 1.9x median) |
| Peer records CSV (2 PR records) | 🔒 Click to unlock → |
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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 (PR first): Class II recall Z-0153-2027 · SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · TECAR Therapy Device (TC2000, TC2001) (K252288) · Kentrospine Viktr-MIS® Pedicle screw system (K252139) · 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: HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC and 2 Puerto Rico peers
- Puerto Rico FDAPulse records like this one: 2
- HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC's amount: 90th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Puerto Rico peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 268-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC in Puerto Rico?
HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196) by Ethicon Endo-Surgery, LLC was cleared on 2026-09-17 after 268 days of review.
How does HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC compare to other Puerto Rico FDAPulse records?
This is a top-decile record: its amount of 268 is 1.9x the median of 138 across 414 records. It is 48 days old; check the official source for later updates before acting.
HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196) vs. top 3 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196) | PR | 2026-09-17 | This record |
| TECAR Therapy Device (TC2000, TC2001) (K252288) | CN | 2026-10-13 | View record → |
| 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 | Compare HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196) vs 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) → |
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 | Compare HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196) vs PicoreMax (PicoreMax) (K254199) → |
Related records
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