FDA product code FZP: Clip, Implantable
FZP is the FDA product code for clip, implantable. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 178 510(k) submissions under FZP, 15 in the last five years, from 84 different applicants. The average 510(k) review took 99 days (median 70); 253 days on average over the last three years. FDA has posted 45 recalls for FZP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Clip, Implantable |
| Device class | Class II |
| Regulation | 21 CFR 878.4300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for FZP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 66 |
| 2018 | 4 | 140 |
| 2019 | 1 | 84 |
| 2020 | 2 | 170 |
| 2022 | 3 | 248 |
| 2023 | 3 | 86 |
| 2024 | 2 | 450 |
| 2025 | 5 | 107 |
| 2026 | 2 | 201 |
Compare with all 510(k) review times · Search every FZP clearance
Top FZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United States Surgical, A Division of Tyco Healthc | 17 | 2007-11-21 |
| AtriCure, Inc. | 11 | 2018-01-31 |
| ETHICON, Inc. | 11 | 1993-08-24 |
| Cardica, Inc. | 10 | 2010-06-25 |
| Teleflex Medical | 7 | 2025-07-03 |
79 more applicants have FZP clearances. See the full list in Caduvo.
Most recent FZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260677 | Vcd Medical S.R.L. | Vessel Closure Device (VCD177213P) | 2026-09-17 | 199 |
| K254231 | Taiwan Surgical Corporation | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips | 2026-07-20 | 203 |
| K253781 | Taiwan Surgical Corporation | InnoClip Clip Applier | 2025-12-22 | 26 |
| K253903 | Taiwan Surgical Corporation | InnoClip Disposable Clip Applier | 2025-12-22 | 17 |
| K250643 | Hangzhou Kangji Medical Instrument Co., Ltd. | Disposable Polymer Ligation Clips | 2025-11-20 | 261 |
Recalls for FZP devices
45 product recalls in 25 recall events; 1 initiated in the last five years and 4 still open. Most recent: 2023-04-28.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 2 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code FZP?
FZP is the FDA product code for clip, implantable. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel.
What device class is FZP?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code FZP?
Across 178 cleared submissions the average was 99 days from receipt to decision (median 70).
Which companies have the most FZP clearances?
United States Surgical, A Division of Tyco Healthc (17); AtriCure, Inc. (11); ETHICON, Inc. (11); Cardica, Inc. (10); Teleflex Medical (7).
Have FZP devices been recalled?
Yes: 45 product recalls across 25 recall events; the most recent began 2023-04-28.
Next steps
- Run an FDA pathway report with predicate devices for product code FZP
- Run a recall and safety report across every FZP manufacturer
- Watch product code FZP 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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