SURGITEL
FDA 510(k) clearance K934494 · decided 1994-01-25
Clearance details
- K-number
- K934494
- Device name
- SURGITEL
- Applicant
- General Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-15
- Decision date
- 1994-01-25
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- HOH
- Device class
- 1
- Regulation number
- 886.4770
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Ann Arbor, MI, 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 |
|---|---|---|
| LOW-POWER BINOCULAR LOUPE (K875124) | Seiler Instrument & Mfg. Co., Inc. | 1988-02-19 |
| EXETER OPERATING LOUPE (K810817) | Exeter Instruments, Inc. | 1981-04-23 |
Recalls involving this device
No recalls on record reference this clearance.