GDX — Scalpel, One-Piece Class I
FDA Device Classification
Classification Details
- Product Code
- GDX
- 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 |
|---|
| K923689 | surgistar | SURGISTAR BLADES | September 9, 1992 |
| K921167 | micron technology | ULTRABLADE | July 30, 1992 |
| K914086 | icn pharmaceuticals | ICAN CYLINDRICAL SPONGES | October 9, 1991 |
| K904505 | buckman co | CCI CORNEAL SCARIFIER | April 23, 1991 |
| K905380 | depuy | 1-CUT ACL GRAFT KNIFE | December 13, 1990 |
| K895682 | applied medical technologies | VESSEL LOOPS | October 24, 1989 |
| K893033 | l.a.b. instruments | MINI-DIAMOND KNIFE | May 26, 1989 |
| K880028 | oxboro medical intl | OMED DISPOSABLE SCALPEL | January 29, 1988 |
| K871894 | kck industries | KCK INDUSTRIES' SURGICAL INSTRUMENTS | June 23, 1987 |
| K863950 | precision surgical industries | P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL | October 24, 1986 |
| K863213 | keisei medical industrial co | KEISEI SCALPEL (STERILE AND NON-STERILE) | September 2, 1986 |
| K854857 | medelec intl | SCALPEL, ONE-PIECE, DISPOSABLE | December 24, 1985 |
| K853103 | medical dimensions | MCKNIFE | August 6, 1985 |
| K851751 | artiberia | 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1 | June 20, 1985 |
| K834541 | imm enterprises | H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 | January 27, 1984 |
| K833467 | diverse technologies | SURE-CUT | January 27, 1984 |
| K830745 | lab industries | ADT DISPOSABLE SCALPEL W/STAINLESS STEEL | April 12, 1983 |
| K822893 | ascep | G.E.V. DISPOSABLE SCALPELS | October 22, 1982 |
| K822749 | narco scientific | PILLING DIAMOND KNIFE | October 6, 1982 |
| K820869 | van-tec | DISPOSABLE #11 SCALPEL BLADE W/SHORT | May 5, 1982 |