FDA product code GAO: Suture, Nonabsorbable
GAO is the FDA product code for suture, nonabsorbable. It is a Class II device, regulated under 21 CFR 878.4495 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under GAO, from 4 different applicants. The average 510(k) review took 82 days (median 45). 1 PMA application cites this product code. FDA has posted 1 recall for GAO devices.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Nonabsorbable |
| 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 |
Compare with all 510(k) review times · Search every GAO clearance
Top GAO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alto Development Corp. | 1 | 1994-01-07 |
| United States Surgical, A Division of Tyco Healthc | 1 | 1987-08-05 |
| Chathamborough Research Group, Inc. | 1 | 1986-09-30 |
| Unoplast A/S | 1 | 1980-09-26 |
Most recent GAO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932513 | Alto Development Corp. | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | 1994-01-07 | 227 |
| K872532 | United States Surgical, A Division of Tyco Healthc | AUTO SUTURE STAINLESS STEEL SUTURES* | 1987-08-05 | 40 |
| K863034 | Chathamborough Research Group, Inc. | SHARPOINT STAINLESS STEEL SUTURE | 1986-09-30 | 50 |
| K802248 | Unoplast A/S | DISARP ORIGINAL | 1980-09-26 | 10 |
Recalls for GAO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-11.
Frequently asked questions
What is FDA product code GAO?
GAO is the FDA product code for suture, nonabsorbable. 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 GAO?
Class II, regulation 21 CFR 878.4495. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAO?
Across 4 cleared submissions the average was 82 days from receipt to decision (median 45).
Which companies have the most GAO clearances?
Alto Development Corp. (1); United States Surgical, A Division of Tyco Healthc (1); Chathamborough Research Group, Inc. (1); Unoplast A/S (1).
Have GAO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-02-11.
Next steps
- Run an FDA pathway report with predicate devices for product code GAO
- Run a recall and safety report across every GAO manufacturer
- Watch product code GAO 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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