ARTHROSCOPE OPERATIVE KNIFE SET
FDA 510(k) clearance K771851 · decided 1977-10-27
Clearance details
- K-number
- K771851
- Device name
- ARTHROSCOPE OPERATIVE KNIFE SET
- Applicant
- Richard Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-09-29
- Decision date
- 1977-10-27
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- HTS
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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 |
|---|---|---|
| CUSTOM ORTHOPAEDIC TRAYS (PACKS) (K930507) | Associated Medical Products Co. | 1994-02-22 |
| ACUFLEX DISPOSABLE KNIVES (K933921) | Acufex Microsurgical, Inc. | 1994-01-26 |
| SPINAL MICROKNIFE (K882525) | Karlin Technology, Inc. | 1988-09-22 |
| TRIANGULAR KNIFE, DISPOSABLE #TM-1611 (K873713) | Arthropedics, Inc. | 1987-11-02 |
| BANANA KNIFE, DISPOSABLE #TM-1612 (K873714) | Arthropedics, Inc. | 1987-11-02 |
| RETROGRADE KNIFE, DISPOSABLE #TM-1613 (K873711) | Arthropedics, Inc. | 1987-11-02 |
| STANDARD KNIFE, DISPOSABLE #TM-1610 (K873712) | Arthropedics, Inc. | 1987-10-15 |
| ARTHROSCOPY KNIVES (K842820) | Medtech Industries, Inc. | 1984-08-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002) | Richard Wolf Medical Instruments Corp. | 2016-10-14 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001) | Richard Wolf Medical Instruments Corp. | 1998-03-12 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080) | Richard Wolf Medical Instruments Corp. | 1996-09-05 |
| RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013) | Richard Wolf Medical Instruments Corp. | 1991-09-09 |