BETTER-BLADDER (BB)
FDA 510(k) clearance K964337 · decided 1997-05-23
Clearance details
- K-number
- K964337
- Device name
- BETTER-BLADDER (BB)
- Applicant
- Circulatory Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-31
- Decision date
- 1997-05-23
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- FIB
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Oyster Bay, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Circulatory Technology
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.
Recalls involving this device
No recalls on record reference this clearance.