FDA product code GAN: Suture, Absorbable, Synthetic
GAN is the FDA product code for suture, absorbable, synthetic. It is a Class II device, regulated under 21 CFR 878.4830 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under GAN, from 5 different applicants. The average 510(k) review took 232 days (median 170). 2 PMA applications cite this product code. FDA has posted 2 recalls for GAN devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Absorbable, Synthetic |
| 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 GAN clearance
Top GAN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ETHICON, Inc. | 3 | 1996-12-18 |
| Surgical Specialties Corp | 1 | 2000-12-15 |
| Sterile Concepts, Inc. | 1 | 1995-12-01 |
| American Cyanamid Co. | 1 | 1990-07-05 |
| United States Surgical, A Division of Tyco Healthc | 1 | 1990-07-05 |
Most recent GAN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003015 | Surgical Specialties Corp | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD | 2000-12-15 | 79 |
| K964072 | ETHICON, Inc. | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | 1996-12-18 | 68 |
| K960653 | ETHICON, Inc. | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | 1996-03-28 | 42 |
| K951231 | Sterile Concepts, Inc. | ORTHOPEDIC PACKS | 1995-12-01 | 256 |
| K920978 | ETHICON, Inc. | ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED | 1994-02-15 | 715 |
Recalls for GAN devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-10-08.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code GAN?
GAN is the FDA product code for suture, absorbable, synthetic. 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 GAN?
Class II, regulation 21 CFR 878.4830. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAN?
Across 7 cleared submissions the average was 232 days from receipt to decision (median 170).
Which companies have the most GAN clearances?
ETHICON, Inc. (3); Surgical Specialties Corp (1); Sterile Concepts, Inc. (1); American Cyanamid Co. (1); United States Surgical, A Division of Tyco Healthc (1).
Have GAN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-10-08.
Next steps
- Run an FDA pathway report with predicate devices for product code GAN
- Run a recall and safety report across every GAN manufacturer
- Watch product code GAN 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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