FDA product code GAQ: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
GAQ is the FDA product code for suture, nonabsorbable, steel, monofilament and multifilament, sterile. It is a Class II device, regulated under 21 CFR 878.4495 and reviewed by the General and Plastic Surgery panel. FDA has cleared 32 510(k) submissions under GAQ, 1 in the last five years, from 27 different applicants. The average 510(k) review took 166 days (median 136). FDA has posted 6 recalls for GAQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device class | Class II |
| Regulation | 21 CFR 878.4495 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GAQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 232 |
| 2018 | 1 | 199 |
| 2020 | 1 | 90 |
| 2022 | 1 | 477 |
Compare with all 510(k) review times · Search every GAQ clearance
Top GAQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ETHICON, Inc. | 3 | 2017-11-01 |
| Suturtek Incorporated | 3 | 2008-10-14 |
| Synthes (Usa) | 2 | 2005-05-27 |
| Conextions Medical | 1 | 2022-04-22 |
| Foosin Medical Supplies Inc., Ltd. | 1 | 2020-02-19 |
22 more applicants have GAQ clearances. See the full list in Caduvo.
Most recent GAQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203855 | Conextions Medical | CoNextions TR Tendon Repair System | 2022-04-22 | 477 |
| K193209 | Foosin Medical Supplies Inc., Ltd. | Wego-Stainless Steel | 2020-02-19 | 90 |
| K172146 | M/s. Meril Endo Surgery Private Limited. | MERISTEEL | 2018-02-01 | 199 |
| K170767 | ETHICON, Inc. | Surgical Stainless Steel Suture, Stainless Steel Suture | 2017-11-01 | 232 |
| K141007 | Demetech Corp. | DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE | 2014-09-25 | 160 |
Recalls for GAQ devices
6 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code GAQ?
GAQ is the FDA product code for suture, nonabsorbable, steel, monofilament and multifilament, sterile. It is a Class II device, regulated under 21 CFR 878.4495 and reviewed by the General and Plastic Surgery panel.
What device class is GAQ?
Class II, regulation 21 CFR 878.4495. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAQ?
Across 32 cleared submissions the average was 166 days from receipt to decision (median 136).
Which companies have the most GAQ clearances?
ETHICON, Inc. (3); Suturtek Incorporated (3); Synthes (Usa) (2); Conextions Medical (1); Foosin Medical Supplies Inc., Ltd. (1).
Have GAQ devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code GAQ
- Run a recall and safety report across every GAQ manufacturer
- Watch product code GAQ 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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