GDY — Gauze/Sponge, Internal, X-Ray Detectable Class I
FDA product code GDY covers "Gauze/Sponge, Internal, X-Ray Detectable", a Class I medical device regulated under 21 CFR 878.4450. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GDY
- Device Class
- Class I
- Regulation Number
- 878.4450
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972634 | ultracell medical technologies | ULTRACELL SUCTION SPONGE | December 17, 1997 |
| K960236 | custom pack reliability | CPR LAP SPONGES | March 28, 1996 |
| K955599 | stryker | STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE | February 22, 1996 |
| K955322 | derivados de gasa, s.a. de c.v | PROTEC X-RAY DETECTABLE GAUZE SPONGE | December 19, 1995 |
| K953830 | kentron health care | KENSORB | October 3, 1995 |
| K953062 | medical perspectives | CHERRY DISSECTOR | September 14, 1995 |
| K953057 | medical perspectives | CYLINDRICAL SPONGE | September 14, 1995 |
| K953088 | medical perspectives | TRIANGULAR SPONGES | September 14, 1995 |
| K953087 | medical perspectives | CHERRY PIT DISSECTOR | September 14, 1995 |
| K953060 | medical perspectives | ROSEBUD DISSECTOR | September 14, 1995 |
| K953059 | medical perspectives | KITTNER DISSECTOR | September 14, 1995 |
| K953058 | medical perspectives | ROUND STICK SPONGES, FLAT STICK SPONGES | September 14, 1995 |
| K951911 | commercial resources new mexico | GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | June 21, 1995 |
| K950372 | ultracell medical technologies | ULTRACELL ORTHOPEDIC SPONGES | April 17, 1995 |
| K950370 | ultracell medical technologies | ULTRACELL ORTHOPEDIC SPONGES | April 17, 1995 |
| K950373 | ultracell medical technologies | ULTRACELL ORTHOPEDIC SPONGES | April 17, 1995 |
| K950659 | ultracell medical technologies | ULTRACELL RETRACTOR COVERS | April 13, 1995 |
| K945606 | lorrex health products | TRIANGULAR SPONGES | December 28, 1994 |
| K945335 | lorrex health products | CHERRY DISSECTOR | December 28, 1994 |
| K945553 | lorrex health products | ROUND STICK SPONGES, FLAT STICK SPONGES | December 28, 1994 |