Product code EMF
- Device name
- Knife, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080133 | MOUNTABLE ENDOSCOPIC BLADE | A.M. Surgical, Inc. | 2008-03-13 |
| K982142 | MOUNTABLE ENDOSCOPIC KNIFE | A.M. Surgical, Inc. | 1998-12-30 |
| K890217 | MICROSURGICAL KNIVES | Kinetic Medical Products | 1989-01-27 |
| K890215 | MICROSURGICAL SCARIFIER | Kinetic Medical Products | 1989-01-27 |
| K890214 | MICROSURGERY RAZOR BLADE HOLDER | Kinetic Medical Products | 1989-01-27 |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | Van-Tec, Inc. | 1988-02-29 |
| K863752 | VALTRAC (BAR) REMOVER DEVICE | Davis & Geck, Inc. | 1986-10-24 |
| K863549 | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | Surgipath Medical Industries, Inc. | 1986-09-30 |
| K861947 | SURGICAL KNIFE | Sharpoint, Inc. | 1986-06-06 |
| K854891 | KNIFE | Euro-Med Intl. | 1986-05-02 |
| K851784 | 27-210 PLASTER KNIFE (REINER) | Artiberia | 1985-06-20 |
| K843497 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | 1984-10-31 |
| K843371 | VALVOTOMY KNIFE | Downs Surgical , Ltd. | 1984-10-25 |
| K834197 | JAKOBI SURG. INSTR- #11 38/39/45/46/67 | Imm Enterprises , Ltd. | 1984-01-27 |
| K834184 | H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 | Imm Enterprises , Ltd. | 1984-01-27 |
| K832368 | CHANGING METHOD OF STERILITY RELEASE | Devon Industries, Inc. | 1983-10-31 |
| K821769 | MICROKNIFE | Biological & Environmental Control Laboratories | 1982-09-14 |
| K801585 | HESSBURG-BFRRON TREPHINE | Precision Instruments, Inc. | 1980-10-03 |
| K791286 | WECK MICROSURGICAL KNIFE | Vista Medical Products, Inc. | 1979-07-24 |
| K780991 | PARALLEL BLADE MARKER | Nestor Engineering Associates, Inc. | 1978-10-03 |
| K780989 | DEVIN-NESTOR SQUARE KNIFE | Nestor Engineering Associates, Inc. | 1978-10-03 |
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| 10649111143793 | Sklar | SKLAR CORPORATION | 2019-05-13 |
| 10649111028212 | Sklar | SKLAR CORPORATION | 2019-05-07 |
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| 10381780508045 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-12 |
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