URETERAL ACCESS SHEATH SET (UASS)
FDA 510(k) clearance K022135 · decided 2002-09-13
Clearance details
- K-number
- K022135
- Device name
- URETERAL ACCESS SHEATH SET (UASS)
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2002-07-01
- Decision date
- 2002-09-13
- Days to decision
- 74 days
- Clearance type
- Abbreviated
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boston Scientific 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.
Recalls involving this device
No recalls on record reference this clearance.