LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
FDA 510(k) clearance K070881 · decided 2007-09-26
Clearance details
- K-number
- K070881
- Device name
- LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
- Applicant
- Sapimed S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-30
- Decision date
- 2007-09-26
- Days to decision
- 180 days
- Clearance type
- Traditional
- Product code
- FHN
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sapimed S.P.A.
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.