GDX — Scalpel, One-Piece Class I
FDA product code GDX covers "Scalpel, One-Piece", a Class I medical device regulated under 21 CFR 878.4800. 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
- GDX
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- 510(k) Exempt
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K923689 | Surgistar | SURGISTAR BLADES | Sep 9, 1992 |
| K921167 | Micron Technology | ULTRABLADE | Jul 30, 1992 |
| K914086 | Icn Pharmaceuticals | ICAN CYLINDRICAL SPONGES | Oct 9, 1991 |
| K904505 | Buckman Co | CCI CORNEAL SCARIFIER | Apr 23, 1991 |
| K905380 | Depuy | 1-CUT ACL GRAFT KNIFE | Dec 13, 1990 |
| K895682 | Applied Medical Technologies | VESSEL LOOPS | Oct 24, 1989 |
| K893033 | L.A.B. Instruments | MINI-DIAMOND KNIFE | May 26, 1989 |
| K880028 | Oxboro Medical Intl | OMED DISPOSABLE SCALPEL | Jan 29, 1988 |
| K871894 | Kck Industries | KCK INDUSTRIES' SURGICAL INSTRUMENTS | Jun 23, 1987 |
| K863950 | Precision Surgical Industries | P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL | Oct 24, 1986 |
| K863213 | Keisei Medical Industrial Co | KEISEI SCALPEL (STERILE AND NON-STERILE) | Sep 2, 1986 |
| K854857 | Medelec Intl | SCALPEL, ONE-PIECE, DISPOSABLE | Dec 24, 1985 |
| K853103 | Medical Dimensions | MCKNIFE | Aug 6, 1985 |
| K851751 | Artiberia | 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1 | Jun 20, 1985 |
| K834541 | Imm Enterprises | H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 | Jan 27, 1984 |
| K833467 | Diverse Technologies | SURE-CUT | Jan 27, 1984 |
| K830745 | Lab Industries | ADT DISPOSABLE SCALPEL W/STAINLESS STEEL | Apr 12, 1983 |
| K822893 | Ascep | G.E.V. DISPOSABLE SCALPELS | Oct 22, 1982 |
| K822749 | Narco Scientific | PILLING DIAMOND KNIFE | Oct 6, 1982 |
| K820869 | Van-Tec | DISPOSABLE #11 SCALPEL BLADE W/SHORT | May 5, 1982 |