INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
FDA 510(k) clearance K972506 · decided 1997-10-01
Clearance details
- K-number
- K972506
- Device name
- INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
- Applicant
- Infinitech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-03
- Decision date
- 1997-10-01
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HJM
- Device class
- 2
- Regulation number
- 886.1945
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chesterfield, MO, 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 |
|---|---|---|
| PEREGRINE DIFFUSION LIGHT PIPE (K950529) | Peregrine Surgical , Ltd. | 1995-06-07 |
| WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (K945877) | Wells Johnson Co. | 1995-03-02 |
| HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE (K931072) | Hgm, Inc. | 1994-11-10 |
| DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) (K933445) | Storz Instrument Co. | 1994-09-23 |
| PEREGRINE WIDE ANGLE LIGHT PIPE (K940393) | Peregrine Surgical , Ltd. | 1994-09-02 |
| FIBEROPTIC ILLUMINATED INSTRUMENTS (K934269) | Visitec Co. | 1994-05-17 |
| DROLITE(TM) LIGHT SOURCE (K913273) | Vision Medical, Inc. | 1991-12-04 |
| DIATHRON(R) DIATHERMY UNIT (K894513) | Intl. Ophthalmic Industries Corp. | 1989-10-31 |
| VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) (K893170) | Keeler Instruments, Inc. | 1989-06-05 |
| RMI TRANSILLUMINATOR, MODEL 292 (K812949) | Radiation Measurements, Inc. | 1981-12-02 |
| RMI TRANSILLUMINATION LIGHT METER #295 (K811108) | Radiation Measurements, Inc. | 1981-07-01 |
Recalls involving this device
No recalls on record reference this clearance.