PENTAX FLEXIBLE DRIODENOFIBERSCOPE
FDA 510(k) clearance K812810 · decided 1981-11-17
Clearance details
- K-number
- K812810
- Device name
- PENTAX FLEXIBLE DRIODENOFIBERSCOPE
- Applicant
- Pentax Precision Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-06
- Decision date
- 1981-11-17
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- FAK
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| MODEL TX-8 PANENDOSCOPE (K760822) | American Cystocope Makers, Inc. | 1976-10-21 |
Recalls involving this device
No recalls on record reference this clearance.