ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
FDA 510(k) clearance K964561 · decided 1997-02-11
Clearance details
- K-number
- K964561
- Device name
- ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
- Applicant
- Bioenterics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-13
- Decision date
- 1997-02-11
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FDG
- Device class
- 1
- Regulation number
- 876.4530
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Carpinteria, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bioenterics Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHAKOFF ENDOSCOPY (K945421) | Stephen Chakoff, Inc. | 1994-12-23 |
Recalls involving this device
No recalls on record reference this clearance.