Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230251 FDA 510(k)
- FDA Product Code
- NUJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a bipolar electrosurgical instrument. It is intended for use in open surgical procedures where ligation of vessels is required.
This device is reprocessed and supplied as a single-use accessory. It is classified as a Class II medical device under FDA regulation number 878.4400 and has received FDA 510(k) clearance (K230251) as substantially equivalent to a predicate device.
Frequently asked questions
What is the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) used for?
It is intended for use in open surgical procedures where ligation of vessels is required. As a bipolar electrosurgical instrument, it seals and divides vessels during surgery, providing hemostasis in open surgical settings.
How is the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) supplied and is it reusable?
The device is reprocessed and supplied as a single-use accessory. It is designed for one-time use only after reprocessing and should not be reused, as indicated by its single-use accessory classification in the device data.
What regulatory pathway was used for the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)?
The device received FDA 510(k) clearance (K230251) as substantially equivalent to a predicate device. It is classified as a Class II medical device under FDA regulation number 878.4400, based on the authorization and classification details provided.
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: Reprocessed LigaSure™ vessel sealing device - Stryker, PDF Stryker's Sustainability Solutions Reprocessed LigaSure Curved, Small ..., Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A ..., PDF Small Jaw (LF1212A) Sell Sheet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230251 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Sustainability Solutions
Sources (1)
- FDA 510(k) K230251 24 fields · synced Sep 27, 2026