MICROSURGICAL BLADE
FDA 510(k) clearance K812160 · decided 1981-08-31
Clearance details
- K-number
- K812160
- Device name
- MICROSURGICAL BLADE
- Applicant
- Vxtra Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-29
- Decision date
- 1981-08-31
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- GES
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| PERSONNA PLUS SAFETY SCALPEL SYSTEM (K032242) | Omi Manufacturing Pty., Ltd. | 2003-09-23 |
| EASY-ON (K932998) | Devon Industries, Inc. | 1993-08-18 |
| LOS ALAMOS RETRACTABLE KNIFE (K923170) | Innovative Surgical Technology, Inc. | 1993-02-18 |
| SCALPEL BLADE REMOVER (BLADEGARD) (K915119) | Intergrated Visual, Inc. | 1992-05-05 |
| PRECISION GLIDE - ENHANCED SURGICAL BLADE (K911913) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-05-13 |
| STERILE CARBON STEEL SURGICAL BLADE (K900266) | Rahn Laboratories | 1990-03-01 |
| ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (K884862) | Anchor Products Co. | 1988-12-27 |
| SURGICAL BLADE (K881638) | Far East Intl. Trading Corp. | 1988-06-15 |
| SURGICAL BLADES (K880244) | Ailee C/O Havel'S, Inc. | 1988-02-10 |
| NINJA SCALPEL (K873493) | Primrose Medical, Inc. | 1987-09-24 |
| PERSONNA DISPOSABLE SCALPEL (K873142) | American Safety Razor Co. | 1987-09-04 |
| DEXTRA DISPOSABLE BLADES (K863867) | Storz Instrument Co. | 1986-10-24 |
Recalls involving this device
No recalls on record reference this clearance.