MOUNTABLE ENDOSCOPIC BLADE
FDA 510(k) clearance K080133 · decided 2008-03-13
Clearance details
- K-number
- K080133
- Device name
- MOUNTABLE ENDOSCOPIC BLADE
- Applicant
- A.M. Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-18
- Decision date
- 2008-03-13
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- EMF
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Smithtown, NY, 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 |
|---|---|---|
| MOUNTABLE ENDOSCOPIC KNIFE (K982142) | A.M. Surgical, Inc. | 1998-12-30 |
| MICROSURGICAL KNIVES (K890217) | Kinetic Medical Products | 1989-01-27 |
| MICROSURGICAL SCARIFIER (K890215) | Kinetic Medical Products | 1989-01-27 |
| MICROSURGERY RAZOR BLADE HOLDER (K890214) | Kinetic Medical Products | 1989-01-27 |
| VAN-TEC ENDOPYELOTOMY KNIFE (K880094) | Van-Tec, Inc. | 1988-02-29 |
| VALTRAC (BAR) REMOVER DEVICE (K863752) | Davis & Geck, Inc. | 1986-10-24 |
| REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (K863549) | Surgipath Medical Industries, Inc. | 1986-09-30 |
| SURGICAL KNIFE (K861947) | Sharpoint, Inc. | 1986-06-06 |
| KNIFE (K854891) | Euro-Med Intl. | 1986-05-02 |
| 27-210 PLASTER KNIFE (REINER) (K851784) | Artiberia | 1985-06-20 |
| SURGICAL KNIVES & PROBES (K843497) | Eder Instrument Co, Inc. | 1984-10-31 |
| VALVOTOMY KNIFE (K843371) | Downs Surgical , Ltd. | 1984-10-25 |
Recalls involving this device
No recalls on record reference this clearance.