PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
FDA 510(k) clearance K013921 · decided 2002-10-17
Clearance details
- K-number
- K013921
- Device name
- PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
- Applicant
- Porges S.A.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-27
- Decision date
- 2002-10-17
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- FAD
- Device class
- 2
- Regulation number
- 876.4620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Le Plessis Robinson Cedex, FR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Porges S.A.
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.