SCALPEL, ONE-PIECE, DISPOSABLE
FDA 510(k) clearance K854857 · decided 1985-12-24
Clearance details
- K-number
- K854857
- Device name
- SCALPEL, ONE-PIECE, DISPOSABLE
- Applicant
- Medelec Intl. Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-05
- Decision date
- 1985-12-24
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- GDX
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Miami Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SURGISTAR BLADES (K923689) | Surgistar, Inc. | 1992-09-09 |
| ULTRABLADE (K921167) | Micron Technology, Inc. | 1992-07-30 |
| ICAN CYLINDRICAL SPONGES (K914086) | Icn Pharmaceuticals, Inc. | 1991-10-09 |
| CCI CORNEAL SCARIFIER (K904505) | Buckman Co., Inc. | 1991-04-23 |
| 1-CUT ACL GRAFT KNIFE (K905380) | Depuy, Inc. | 1990-12-13 |
| VESSEL LOOPS (K895682) | Applied Medical Technologies | 1989-10-24 |
| MINI-DIAMOND KNIFE (K893033) | L.A.B. Instruments | 1989-05-26 |
| OMED DISPOSABLE SCALPEL (K880028) | Oxboro Medical Intl., Inc. | 1988-01-29 |
| KCK INDUSTRIES' SURGICAL INSTRUMENTS (K871894) | Kck Industries | 1987-06-23 |
| P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL (K863950) | Precision Surgical Industries, Inc. | 1986-10-24 |
| KEISEI SCALPEL (STERILE AND NON-STERILE) (K863213) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| MCKNIFE (K853103) | Medical Dimensions | 1985-08-06 |
Recalls involving this device
No recalls on record reference this clearance.