FDA product code PKL: Hemostatic Metal Clip For The Gi Tract
PKL is the FDA product code for hemostatic metal clip for the gi tract. It is a Class II device, regulated under 21 CFR 876.4400 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 65 510(k) submissions under PKL, 30 in the last five years, from 28 different applicants. The average 510(k) review took 166 days (median 161); 173 days on average over the last three years. FDA has posted 6 recalls for PKL devices, 5 initiated in the last five years.
Definition
Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.
Classification
| Field | Value |
|---|---|
| Device name | Hemostatic Metal Clip For The Gi Tract |
| Device class | Class II |
| Regulation | 21 CFR 876.4400 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for PKL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 174 |
| 2018 | 5 | 127 |
| 2019 | 4 | 204 |
| 2020 | 6 | 172 |
| 2021 | 2 | 90 |
| 2022 | 9 | 214 |
| 2023 | 2 | 230 |
| 2024 | 8 | 167 |
| 2025 | 6 | 145 |
| 2026 | 5 | 206 |
Compare with all 510(k) review times · Search every PKL clearance
Top PKL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ovesco Endoscopy AG | 9 | 2026-09-14 |
| Micro-Tech (Nanjing) Co., Ltd. | 8 | 2025-09-08 |
| Boston Scientific Corporation | 8 | 2025-02-06 |
| Hangzhou AGS MedTech Co., Ltd. | 6 | 2026-08-10 |
| Olympus Medical Systems Corp. | 4 | 2026-05-21 |
23 more applicants have PKL clearances. See the full list in Caduvo.
Most recent PKL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253481 | Ovesco Endoscopy AG | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | 2026-09-14 | 335 |
| K254069 | Hangzhou AGS MedTech Co., Ltd. | Hemoclip (511 series, 543 series) | 2026-08-10 | 235 |
| K260580 | Olympus Medical Systems Corp. | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | 2026-05-21 | 90 |
| K252270 | Hangzhou AGS MedTech Co., Ltd. | Hemoclip | 2026-04-08 | 261 |
| K253734 | Taurus Endoscopy | Taurus Clip | 2026-03-12 | 108 |
Recalls for PKL devices
6 product recalls in 3 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-03-03.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 4 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code PKL?
PKL is the FDA product code for hemostatic metal clip for the gi tract. It is a Class II device, regulated under 21 CFR 876.4400 and reviewed by the Gastroenterology and Urology panel.
What device class is PKL?
Class II, regulation 21 CFR 876.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code PKL?
Across 65 cleared submissions the average was 166 days from receipt to decision (median 161).
Which companies have the most PKL clearances?
Ovesco Endoscopy AG (9); Micro-Tech (Nanjing) Co., Ltd. (8); Boston Scientific Corporation (8); Hangzhou AGS MedTech Co., Ltd. (6); Olympus Medical Systems Corp. (4).
Have PKL devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2026-03-03.
Next steps
- Run an FDA pathway report with predicate devices for product code PKL
- Run a recall and safety report across every PKL manufacturer
- Watch product code PKL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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