FDA Product Code
FDA Product Code GDX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K923689 | SURGISTAR BLADES | Surgistar, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K921167 | ULTRABLADE | Micron Technology, Inc. | 1992-07-30 | Traditional | PDF ↗ |
| K914086 | ICAN CYLINDRICAL SPONGES | Icn Pharmaceuticals, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K904505 | CCI CORNEAL SCARIFIER | Buckman Co., Inc. | 1991-04-23 | Traditional | PDF ↗ |
| K905380 | 1-CUT ACL GRAFT KNIFE | Depuy, Inc. | 1990-12-13 | Traditional | PDF ↗ |
| K895682 | VESSEL LOOPS | Applied Medical Technologies | 1989-10-24 | Traditional | PDF ↗ |
| K893033 | MINI-DIAMOND KNIFE | L.A.B. Instruments | 1989-05-26 | Traditional | PDF ↗ |
| K880028 | OMED DISPOSABLE SCALPEL | Oxboro Medical Intl., Inc. | 1988-01-29 | Traditional | PDF ↗ |
| K871894 | KCK INDUSTRIES' SURGICAL INSTRUMENTS | Kck Industries | 1987-06-23 | Traditional | PDF ↗ |
| K863950 | P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL | Precision Surgical Industries, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K863213 | KEISEI SCALPEL (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 | Traditional | PDF ↗ |
| K854857 | SCALPEL, ONE-PIECE, DISPOSABLE | Medelec Intl. Corp. | 1985-12-24 | Traditional | PDF ↗ |
| K853103 | MCKNIFE | Medical Dimensions | 1985-08-06 | Traditional | PDF ↗ |
| K851751 | 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1 | Artiberia | 1985-06-20 | Traditional | PDF ↗ |
| K834541 | H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 | Imm Enterprises , Ltd. | 1984-01-27 | Traditional | PDF ↗ |
| K833467 | SURE-CUT | Diverse Technologies, Inc. | 1984-01-27 | Traditional | PDF ↗ |
| K830745 | ADT DISPOSABLE SCALPEL W/STAINLESS STEEL | Lab Industries, Inc. | 1983-04-12 | Traditional | PDF ↗ |
| K822893 | G.E.V. DISPOSABLE SCALPELS | Ascep, Inc. | 1982-10-22 | Traditional | PDF ↗ |
| K822749 | PILLING DIAMOND KNIFE | Narco Scientific | 1982-10-06 | Traditional | PDF ↗ |
| K820869 | DISPOSABLE #11 SCALPEL BLADE W/SHORT | Van-Tec, Inc. | 1982-05-05 | Traditional | PDF ↗ |
| K820730 | MICRO CISE DIAMOND SCALPEL | CooperVision, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K813422 | SCALPEL | Abco Dealers, Inc. | 1982-01-05 | Traditional | PDF ↗ |
| K811707 | AXICUT DISPOSABLE SCALPEL | Neonatal Corp. | 1981-07-20 | Traditional | PDF ↗ |
| K800177 | I.M. BLADES | Instrument Makar, Inc. | 1980-02-11 | Traditional | PDF ↗ |
| K790259 | STERILE DISPOSABLE KNIFE | Intermedics, Inc. | 1979-02-13 | Traditional | PDF ↗ |
| K780998 | SCALPEL | Isolab, Inc. | 1978-07-27 | Traditional | PDF ↗ |
Product code GDX · Class I · General, Plastic Surgery. Data: openFDA.