Identity
- Trade Name
- neoClose 2 Anchor (Long Driver) US FDA UDI
- Generic Name
- Laparoscopic wound closure thread FDA UDI
- Device Name
- Laparoscopy wound closure system pack consists of: 05391529640439; neoClose Anchor (Long Driver) x 2 US; Model Number NCAALX2-U FDA UDI
- Model / Reference
- NCAALX2-U FDA UDI
- Description
- Laparoscopy wound closure system pack consists of: 05391529640439; neoClose Anchor (Long Driver) x 2 US; Model Number NCAALX2-U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391529640552 FDA UDI
- 510(k) Number
- K142903 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
No
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
neoClose 2 Anchor (Long Driver) US by Neosurgical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic wound closure thread.
- Monopolar posts long for handles — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
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- Carter-Thomason CloseSure System® — CooperSurgical, Inc. · Class II
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- Advanced Endodontic System — ASI MEDICAL, INC. · U
- Lap Port Closure Device Bariatric Kit — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- Carter-Thomason (REGARD Distributed) — CooperSurgical, Inc. · Class II
- Trocar Swab Kit — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
Cleared under the same submission
K142903 also covers:
- neoClose 2 AutoAnchor Pack US — Neosurgical, Ltd.
- neoClose 4 AutoAnchor Pack US — Neosurgical, Ltd.
- neoClose AnchorGuide 5/12 Port Closure Kit US (1 Port) — Neosurgical, Ltd.
- neoClose AnchorGuide 5/15 Port Closure Kit US (2 Port) — Neosurgical, Ltd.
- neoClose AnchorGuide 8/15 Port Closure Kit US (1 Port) — Neosurgical, Ltd.
- neoClose AnchorGuide Regular Port Closure Kit US — Neosurgical, Ltd.
- neoClose AnchorGuide Regular Port Closure Kit x2 US — Neosurgical, Ltd.
- neoClose AnchorGuide XL Port Closure Kit US — Neosurgical, Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neosurgical, Ltd.
Sources (1)
- FDA UDI 8fceaa71-09e4-4f8f-8d76-5608f4753289 34 fields · synced May 30, 2026