FDA product code GAL: Suture, Absorbable, Natural
GAL is the FDA product code for suture, absorbable, natural. It is a Class II device, regulated under 21 CFR 878.4830 and reviewed by the General and Plastic Surgery panel. FDA has cleared 30 510(k) submissions under GAL, from 23 different applicants. The average 510(k) review took 189 days (median 158). 8 PMA applications cite this product code. FDA has posted 5 recalls for GAL devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Absorbable, Natural |
| Device class | Class II |
| Regulation | 21 CFR 878.4830 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every GAL clearance
Top GAL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United States Surgical, A Division of Tyco Healthc | 4 | 1994-04-28 |
| Look, Inc. | 3 | 1993-12-22 |
| Sutures , Ltd. | 2 | 1994-12-05 |
| Surgimetrics International, Ltd. | 2 | 1994-03-03 |
| Covidien | 1 | 2015-01-29 |
18 more applicants have GAL clearances. See the full list in Caduvo.
Most recent GAL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142656 | Covidien | Surgical Gut Suture | 2015-01-29 | 133 |
| K072930 | Demetech Corp. | DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT | 2008-04-30 | 197 |
| K042287 | United Medical Industries Co. , Ltd. | UNIPLAIN & UNICHROM | 2005-09-07 | 379 |
| K042897 | Ethicon Endo-Surgery, Inc. | AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE | 2004-11-19 | 30 |
| K030227 | Suturtek Incorporated | SUTURTEK FASTCLOSE SUTURING DEVICE | 2003-03-17 | 54 |
Recalls for GAL devices
5 product recalls in 3 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2023-03-01.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 3 |
Frequently asked questions
What is FDA product code GAL?
GAL is the FDA product code for suture, absorbable, natural. It is a Class II device, regulated under 21 CFR 878.4830 and reviewed by the General and Plastic Surgery panel.
What device class is GAL?
Class II, regulation 21 CFR 878.4830. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAL?
Across 30 cleared submissions the average was 189 days from receipt to decision (median 158).
Which companies have the most GAL clearances?
United States Surgical, A Division of Tyco Healthc (4); Look, Inc. (3); Sutures , Ltd. (2); Surgimetrics International, Ltd. (2); Covidien (1).
Have GAL devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2023-03-01.
Next steps
- Run an FDA pathway report with predicate devices for product code GAL
- Run a recall and safety report across every GAL manufacturer
- Watch product code GAL 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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