Modification to Implantable Clip
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K011236 FDA 510(k)
- FDA Product Code
- FZP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an implantable clip, a surgical instrument designed for securing or ligating tubular anatomical structures or blood vessels. It is classified under the FDA’s general and plastic surgery category and is intended for use in laparoscopic and general surgical procedures to provide hemostasis or occlusion.
The modification to the implantable clip is supplied as a sterile, single-use device and is regulated under FDA’s 510(k) clearance pathway. It is intended for use in controlled surgical environments and must comply with FDA’s Class II device regulations (21 CFR 878.4300). No MRI safety information or reusable variants are specified in the regulatory data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Modification To Implantable Clip 510 (k) FDA Premarket Notification ..., PDF K011236 - Modification to Implantable Clip, IMPLANTABLE CLIP FOR GENERAL SURGERY by APPLIED MEDICAL RESOURCES | FDA ..., APPLIED MEDICAL RESOURCES CORP. FDA Filings - FDA.report, K011236 - Clip, Implantable FDA 510 (k) APPLICATION FOR APPLIED MEDICAL ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011236 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA 510(k) K011236 24 fields · synced Sep 19, 2026