SUTURE APPLIER DEVICE
FDA 510(k) clearance K905722 · decided 1991-03-14
Clearance details
- K-number
- K905722
- Device name
- SUTURE APPLIER DEVICE
- Applicant
- Laparomed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-20
- Decision date
- 1991-03-14
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- MFJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Laparomed 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.
Recalls involving this device
No recalls on record reference this clearance.