GDT — Staple, Removable (Skin) Class I
FDA product code GDT covers "Staple, Removable (Skin)", a Class I medical device regulated under 21 CFR 878.4760. Submissions are reviewed by the General, Plastic Surgery panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GDT
- Device Class
- Class I
- Regulation Number
- 878.4760
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K963234 | continental medical laboratories | STAPLE REMOVAL KIT | October 21, 1996 |
| K943719 | pilling weck | VISISTAT STAPLER | August 24, 1994 |
| K925526 | matsutani seisakusho co. | MANIPLER DISPOSABLE SKIN STAPLER | June 24, 1993 |
| K915430 | cypress medical products | SKIN STAPLE REMOVER KIT | February 28, 1992 |
| K911204 | deroyal industries | QUALTEX SKIN STAPLE EXTRACTOR | May 8, 1991 |
| K910586 | united states surgical, a division of tyco healthc | AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* | March 7, 1991 |
| K900486 | davis and geck | APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER | April 20, 1990 |
| K861711 | busse hospital disposables | SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE | May 16, 1986 |
| K851974 | american v. mueller | V. MUELLER VITAL SKIN STAPLER | June 11, 1985 |
| K844838 | edward weck | SKIN STAT II SKIN STAPLING MEDICAL DEVICE | January 23, 1985 |
| K844837 | edward weck | VISISTAT SKIN STAPLING DEVICE | January 23, 1985 |
| K833085 | prosper | STAPLE REMOVER SR300P | December 14, 1984 |
| K833357 | ethicon | VYDAX 525-550 & 5100 FLUOROTELOMER | December 12, 1983 |
| K832709 | prosper | SKIN STAPLING DEVICE SC2000 | September 26, 1983 |
| K822365 | tri-state | CENTURION SKIN STAPLE REMOVER | August 27, 1982 |
| K821024 | howmedica | DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE | May 14, 1982 |
| K801444 | edward weck | SKIN STAPLE REMOVER #523770 | July 14, 1980 |
| K800535 | 3m | 3M DISPOSABLE SKIN STAPLER | April 4, 1980 |
| K760734 | ethicon | REGULAR AND WIDE SKIN STAPLES | November 3, 1976 |