CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
FDA 510(k) clearance K924407 · decided 1992-09-23
Clearance details
- K-number
- K924407
- Device name
- CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 1992-08-25
- Decision date
- 1992-09-23
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- EXJ
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Fort Woth, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Coloplast A/S
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.