Identity
- Trade Name
- Carter-thomason CloseSure System XL FDA UDI
- Generic Name
- Laparoscopic wound closure thread FDA UDI
- Device Name
- Contents: One Suture Passer XL, one 10/12mm Pilot Guide XL and one 15mm Pilot Guide XL FDA UDI
- Model / Reference
- CTXL FDA UDI
- Description
- Contents: One Suture Passer XL, one 10/12mm Pilot Guide XL and one 15mm Pilot Guide XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937002968 FDA UDI
- 510(k) Number
- K980123 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Laparoscopic wound closure thread FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laparoscopic wound closure thread
Carter-thomason CloseSure System XL by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Laparoscopic wound closure thread.
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- Advanced Endodontic System — ASI MEDICAL, INC. · U
- neoClose 2 AutoAnchor Pack US — Neosurgical, Ltd. · Class II
- Lap Port Closure Device Bariatric Kit — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
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- Lap-port closure device guides 10/12mm and 15 mm Bariatric — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
Cleared under the same submission
K980123 also covers:
- Carter-Thomason — CooperSurgical, Inc.
- Carter-Thomason — CooperSurgical, Inc.
- Carter-Thomason — CooperSurgical, Inc.
- Carter-Thomason (REGARD Distributed) — CooperSurgical, Inc.
- Carter-Thomason (REGARD Distributed) — CooperSurgical, Inc.
- Carter-Thomason CloseSure System — CooperSurgical, Inc.
- Carter-Thomason CloseSure System Pilot Guides — CooperSurgical, Inc.
- Carter-Thomason CloseSure System® — CooperSurgical, Inc.
- Carter-Thomason CloseSure System® (REGARD Distributed) — CooperSurgical, Inc.
- Carter-Thomason II — CooperSurgical, Inc.
- Carter-Thomason II Port Closure System — CooperSurgical, Inc.
- Carter-Thomason II Port Closure System — CooperSurgical, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI 379ad16d-30c8-4da7-a1fe-560b57719ac3 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026