FDA product code GAP: Suture, Nonabsorbable, Silk
GAP is the FDA product code for suture, nonabsorbable, silk. It is a Class II device, regulated under 21 CFR 878.5030 and reviewed by the General and Plastic Surgery panel. FDA has cleared 41 510(k) submissions under GAP, 4 in the last five years, from 34 different applicants. The average 510(k) review took 147 days (median 84); 369 days on average over the last three years. 5 PMA applications cite this product code. FDA has posted 28 recalls for GAP devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Nonabsorbable, Silk |
| Device class | Class II |
| Regulation | 21 CFR 878.5030 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GAP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 95 |
| 2018 | 1 | 101 |
| 2023 | 1 | 409 |
| 2024 | 3 | 369 |
Compare with all 510(k) review times · Search every GAP clearance
Top GAP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United States Surgical, A Division of Tyco Healthc | 5 | 1998-05-11 |
| Safepath Medical, Inc. | 2 | 2024-10-18 |
| M/s. Meril Endo Surgery Private Limited. | 2 | 2017-10-20 |
| Surgical Specialties, Inc. | 2 | 1994-01-07 |
| Covidien | 1 | 2024-12-03 |
29 more applicants have GAP clearances. See the full list in Caduvo.
Most recent GAP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241486 | Covidien | Sofsilk Coated Braided Silk Suture | 2024-12-03 | 193 |
| K222944 | Safepath Medical, Inc. | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture | 2024-10-18 | 753 |
| K232355 | Shandong Haidike Medical Product Co., Ltd. | Non absorbable Surgical Silk Suture | 2024-01-16 | 162 |
| K221767 | Huaian Seamen Medical Technology Co., Ltd. | Surgical Sutures with or without Needle | 2023-07-31 | 409 |
| K180701 | Safepath Medical, Inc. | SafePath Suturing System | 2018-06-25 | 101 |
Recalls for GAP devices
28 product recalls in 8 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2024-01-25.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code GAP?
GAP is the FDA product code for suture, nonabsorbable, silk. It is a Class II device, regulated under 21 CFR 878.5030 and reviewed by the General and Plastic Surgery panel.
What device class is GAP?
Class II, regulation 21 CFR 878.5030. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAP?
Across 41 cleared submissions the average was 147 days from receipt to decision (median 84).
Which companies have the most GAP clearances?
United States Surgical, A Division of Tyco Healthc (5); Safepath Medical, Inc. (2); M/s. Meril Endo Surgery Private Limited. (2); Surgical Specialties, Inc. (2); Covidien (1).
Have GAP devices been recalled?
Yes: 28 product recalls across 8 recall events; the most recent began 2024-01-25.
Next steps
- Run an FDA pathway report with predicate devices for product code GAP
- Run a recall and safety report across every GAP manufacturer
- Watch product code GAP 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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