DISPOSABLE SUTURE PLACEMENT SYSTEM
FDA 510(k) clearance K932553 · decided 1994-05-12
Clearance details
- K-number
- K932553
- Device name
- DISPOSABLE SUTURE PLACEMENT SYSTEM
- Applicant
- Laurus Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-26
- Decision date
- 1994-05-12
- Days to decision
- 351 days
- Clearance type
- Traditional
- Product code
- GCJ
- 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 Laurus Medical 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
| Record | Firm | Date |
|---|---|---|
| Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transv recall (Z-1618-2018) | Boston Scientific Corporation | 2018-05-04 |
| Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing recall (Z-1620-2018) | Boston Scientific Corporation | 2018-05-04 |