CHAKOFF ENDOSCOPY
FDA 510(k) clearance K945421 · decided 1994-12-23
Clearance details
- K-number
- K945421
- Device name
- CHAKOFF ENDOSCOPY
- Applicant
- Stephen Chakoff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-04
- Decision date
- 1994-12-23
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- FDG
- Device class
- 1
- Regulation number
- 876.4530
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miami, FL, 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 |
|---|---|---|
| ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA (K964561) | Bioenterics Corp. | 1997-02-11 |
Recalls involving this device
No recalls on record reference this clearance.