Identifiers
- 510(k) Number
- K152134 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)
A reprocessed electrosurgical vessel sealer is a bipolar instrument designed for use with the ForceTriad™ Energy Platform in general, minimally invasive, and open surgical procedures where ligation and division of vessels and lymphatics is desired. It creates a seal by applying radiofrequency electrosurgical energy to vascular structures, enabling vessel and lymphatic sealing, tissue grasping, and dissection.
The device is supplied in a reprocessed, single-use condition and is intended for use in laparoscopic general and gynecological surgery. It features a 5 mm shaft diameter, 37 cm length, and 159-degree rotation, with distal tip options including blunt or dolphin nose. Regulatory authorization is based on FDA 510(k) clearance under K152134, with device classification as Class II under regulation number 878.4400 and product code NUJ.
Frequently asked questions
What is the Reprocessed Vessel Sealer used for?
It is designed for ligation and division of vessels and lymphatics in general, minimally invasive, and open surgical procedures, enabling vessel sealing, tissue grasping, and dissection via radiofrequency energy applied through the ForceTriad™ Energy Platform.
How is the Reprocessed Vessel Sealer supplied and intended for use?
The device is supplied in a reprocessed, single-use condition and is intended for laparoscopic general and gynecological surgery, meaning it is cleaned, tested, and resterilized for one-time patient use after prior clinical service.
What are the key physical specifications of the Reprocessed Vessel Sealer?
It has a 5 mm shaft diameter, 37 cm working length, and 159-degree rotation capability, with distal tip options available in blunt or dolphin nose configurations to suit different surgical access and tissue manipulation needs.
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 VESSEL SEALER (K123096) — FDA 510(k) | Innolitics, Reprocessed Vessel Sealer (K152134) — FDA 510(k) | Innolitics, Reprocessed Vessel Sealer — FDA 510 (k) K152134 | MedTracker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152134 | Class II | Active |
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Manufacturer
- Manufacturer
- Sterilmed, Inc.
Sources (1)
- FDA 510(k) K152134 24 fields · synced Sep 21, 2026