Identity
- Trade Name
- Anastoclip GC Closure System FDA UDI
- Generic Name
- Surgical clip applier, single-use FDA UDI
- Device Name
- Anastoclip GC Closure System, Large FDA UDI
- Model / Reference
- 4007-07 FDA UDI
- Description
- Anastoclip GC Closure System, Large FDA UDI
Identifiers
- Catalog Number
- 4007-07 FDA UDI
- Primary DI / UDI-DI
- 00840663102464 FDA UDI
- 510(k) Number
- K091987 FDA UDI
- FDA Product Code
- FZP FDA UDI
- GMDN Term
- Surgical clip applier, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Surgical clip applier, single-use
Anastoclip GC Closure System by LeMaitre Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical clip applier, single-use.
- Anastoclip Universal Clip Remover — LeMaitre Vascular, Inc. · Class II
- Anastoclip GC Closure System — LeMaitre Vascular, Inc. · Class II
- Anastoclip AC Closure System — LeMaitre Vascular, Inc. · Class II
- Anastoclip AC Closure System — LeMaitre Vascular, Inc. · Class II
- Anastoclip AC Closure System — LeMaitre Vascular, Inc. · Class II
- Anastoclip GC Closure System — LeMaitre Vascular, Inc. · Class II
- Anastoclip AC Closure System — LeMaitre Vascular, Inc. · Class II
Cleared under the same submission
K091987 also covers:
- AnastoClip GC 8cm (Large) — LeMaitre Vascular, Inc.
- AnastoClip GC 8cm (Medium) — LeMaitre Vascular, Inc.
- AnastoClip GC 8cm (Small) — LeMaitre Vascular, Inc.
- AnastoClip GC 8cm (XLarge) — LeMaitre Vascular, Inc.
- Anastoclip GC Closure System — LeMaitre Vascular, Inc.
- Anastoclip GC Closure System — LeMaitre Vascular, Inc.
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
- LeMaitre Vascular, Inc.
Sources (1)
- FDA UDI 16dd8c8d-17d3-4212-8f62-9dfdd63be211 36 fields · synced Jun 9, 2026