FDA product code GAE: Snare, Surgical
GAE is the FDA product code for snare, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under GAE, from 3 different applicants. The average 510(k) review took 160 days (median 113). FDA has posted 3 recalls for GAE devices.
Classification
| Field | Value |
|---|---|
| Device name | Snare, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GAE clearance
Top GAE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acufex Microsurgical, Inc. | 2 | 1993-05-05 |
| Cook Urological, Inc. | 1 | 1995-04-18 |
| Advance Suture, Inc. | 1 | 1991-07-10 |
Most recent GAE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950776 | Cook Urological, Inc. | BIPOLAR SNARE | 1995-04-18 | 56 |
| K926036 | Acufex Microsurgical, Inc. | ACUFEX SUTURE RETRIEVER | 1993-05-05 | 155 |
| K903174 | Advance Suture, Inc. | ADVANCE SUTURE ABSORBABLE GUT SUTURE | 1991-07-10 | 357 |
| K881224 | Acufex Microsurgical, Inc. | ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE | 1988-06-01 | 71 |
Recalls for GAE devices
3 product recalls in 2 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 GAE?
GAE is the FDA product code for snare, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GAE?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GAE?
Across 4 cleared submissions the average was 160 days from receipt to decision (median 113).
Which companies have the most GAE clearances?
Acufex Microsurgical, Inc. (2); Cook Urological, Inc. (1); Advance Suture, Inc. (1).
Have GAE devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2013-05-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GAE
- Run a recall and safety report across every GAE manufacturer
- Watch product code GAE 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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