Identifiers
- 510(k) Number
- K142350 FDA 510(k)
- FDA Product Code
- GEI 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 PK J-Hook is a surgical device used in general and plastic surgery procedures. It is substantially equivalent to the predicate Gyrus ACMI Plasmacision and Plasmablend electrodes (K050460).
The device is distributed by Gyrus Acmi, Inc. and has received FDA 510(k) clearance under K number K142350. It is manufactured at 136 Tpke. Rd., Southborough, MA 01772.
Frequently asked questions
What is the PK J-HOOK used for?
The PK J-HOOK is a surgical device used in general and plastic surgery procedures, as stated in its description. It is designed for tissue manipulation and dissection during these types of operations, based on its substantial equivalence to predicate devices used in similar surgical contexts.
How is the PK J-HOOK supplied or distributed?
The PK J-HOOK is distributed by Gyrus Acmi, Inc., the manufacturer listed in the device data. It is manufactured at their facility in Southborough, MA, and made available through their distribution channels for use in surgical settings.
What regulatory pathway was used for the PK J-HOOK?
The PK J-HOOK received FDA 510(k) clearance under K number K142350, as indicated in the AUTHORIZATIONS and specifications fields. This means it was found substantially equivalent to a legally marketed predicate device, specifically the Gyrus ACMI Plasmacision and Plasmablend electrodes (K050460).
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: PDF Gyrus Medical Solid Organ Resection Device (SORD), Surgical Technologies | Olympus America | Medical, Pk J-hook 510 (k) FDA Premarket Notification K142350 GYRUS ACMI INC., OLYMPUS - GYRUS ACMI: 956010PC WestCMR
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142350 | Class II | Active |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA 510(k) K142350 24 fields · synced Sep 25, 2026