GAE — Snare, Surgical Class I
FDA product code GAE covers "Snare, Surgical", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAE
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950776 | cook urological | BIPOLAR SNARE | April 18, 1995 |
| K926036 | acufex microsurgical | ACUFEX SUTURE RETRIEVER | May 5, 1993 |
| K903174 | advance suture | ADVANCE SUTURE ABSORBABLE GUT SUTURE | July 10, 1991 |
| K881224 | acufex microsurgical | ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE | June 1, 1988 |