The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc.
The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc. (California): 510(k) cleared for Allwin Medical Devices, Inc. Its amount of 177 is above the median of 138 (63rd percentile). Dated 27 days ago, it is in the active follow-up window. Score 48/100. 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: 177 · 63th percentile of 414 FDAPulse records · 1.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261234 |
| Device | The D-Tip Denudation Pipette |
| Applicant | Allwin Medical Devices, Inc. |
| Specialty / panel | Obstetrics/Gynecology |
| Product code | MQH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-15 |
| Decision date | 2026-10-09 |
| Review time (days) | 177 |
| Third-party review | No |
| Applicant location | Anaheim, CA, US |
| amount percentile | 63th of 414 (median 138, 1.3x median) |
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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: 2026-10-09
- Data refreshed: 2026-11-04
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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: The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc.'s amount: 63rd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 177-day review, longer than typical.
- Posted 27 days ago.
What is the FDAPulse record for The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc. in California?
The D-Tip Denudation Pipette (K261234) by Allwin Medical Devices, Inc. was cleared on 2026-10-09 after 177 days of review.
How does The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc. compare to other California FDAPulse records?
Its amount of 177 sits in the upper half (63th percentile) of 414 records; the median is 138. It is 27 days old, still within a typical 45-day follow-up window.
The D-Tip Denudation Pipette (K261234) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| The D-Tip Denudation Pipette (K261234) | CA | 2026-10-09 |
| UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252) | DE | 2026-09-25 |
| KARL STORZ SUPRALOOP (K254303) | DE | 2026-09-24 |
| Everslide (K260117) | OK | 2026-09-23 |
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- KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG
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