CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
FDA 510(k) clearance K980123 · decided 1998-03-09
Clearance details
- K-number
- K980123
- Device name
- CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
- Applicant
- Louisville Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-14
- Decision date
- 1998-03-09
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Louisville, KY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of recall (Z-0985-2024) | CooperSurgical, Inc. | 2024-02-05 |