FDA product code GAS: Suture, Nonabsorbable, Synthetic, Polyester
GAS is the FDA product code for suture, nonabsorbable, synthetic, polyester. It is a Class II device, regulated under 21 CFR 878.5000 and reviewed by the General and Plastic Surgery panel. FDA has cleared 17 510(k) submissions under GAS, from 13 different applicants. The average 510(k) review took 147 days (median 83). 6 PMA applications cite this product code. FDA has posted 1 recall for GAS devices.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Nonabsorbable, Synthetic, Polyester |
| Device class | Class II |
| Regulation | 21 CFR 878.5000 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GAS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 40 |
Compare with all 510(k) review times · Search every GAS clearance
Top GAS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mitek Surgical Products, Inc. | 4 | 1992-12-30 |
| United States Surgical, A Division of Tyco Healthc | 2 | 1991-01-31 |
| Lsi Solutions, Inc. | 1 | 2020-11-24 |
| Lsi Solutions | 1 | 2020-11-24 |
| Arthrex, Inc. | 1 | 2010-07-30 |
8 more applicants have GAS clearances. See the full list in Caduvo.
Most recent GAS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203081 | Lsi Solutions | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | 2020-11-24 | 42 |
| K203120 | Lsi Solutions, Inc. | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene | 2020-11-24 | 39 |
| K091018 | Arthrex, Inc. | ARTHREX BIOWIRE | 2010-07-30 | 477 |
| K002261 | Smith & Nephew, Inc. | MR-III | 2000-10-23 | 90 |
| K953128 | Phoenix Biomedical Corp. | SUTURE CORD | 1996-02-09 | 218 |
Recalls for GAS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-05-03.
Frequently asked questions
What is FDA product code GAS?
GAS is the FDA product code for suture, nonabsorbable, synthetic, polyester. It is a Class II device, regulated under 21 CFR 878.5000 and reviewed by the General and Plastic Surgery panel.
What device class is GAS?
Class II, regulation 21 CFR 878.5000. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAS?
Across 17 cleared submissions the average was 147 days from receipt to decision (median 83).
Which companies have the most GAS clearances?
Mitek Surgical Products, Inc. (4); United States Surgical, A Division of Tyco Healthc (2); Lsi Solutions, Inc. (1); Lsi Solutions (1); Arthrex, Inc. (1).
Have GAS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-05-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GAS
- Run a recall and safety report across every GAS manufacturer
- Watch product code GAS 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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