ab medica irrigation/suction gravity system
FDA 510(k) clearance K151822 · decided 2015-09-04
Clearance details
- K-number
- K151822
- Device name
- ab medica irrigation/suction gravity system
- Applicant
- Ab Medica Sas
- Decision
- Substantially Equivalent
- Date received
- 2015-07-06
- Decision date
- 2015-09-04
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mary-Su-Cher, FR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ab Medica Sas
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.