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Co2 For Arthroscopy

FDA 510(k)

Class II (US FDA 510(k))

510(k) K852592

by The Anspach Effort, Inc.

Identifiers

510(k) Number
K852592 FDA 510(k)
FDA Product Code
HRX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.1100 FDA 510(k)
Regulation Number
888.1100 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

CO2 FOR ARTHROSCOPY is a device used in arthroscopic procedures, as indicated by its device name and classification under product code HRX. It was determined to be substantially equivalent to a predicate device through the FDA 510(k) process.

The device received traditional 510(k) clearance (K852592) from the FDA on August 9, 1985, following review by the Orthopedic advisory committee. It is manufactured by The Anspach Effort, Inc. and is authorized for distribution in the United States.

Frequently asked questions

What is CO2 FOR ARTHROSCOPY used for?

CO2 FOR ARTHROSCOPY is a device used in arthroscopic procedures, as indicated by its device name and classification under product code HRX, to support visualization and insufflation during joint surgery.

How was CO2 FOR ARTHROSCOPY cleared for market?

CO2 FOR ARTHROSCOPY received traditional 510(k) clearance (K852592) from the FDA on August 9, 1985, after being determined substantially equivalent to a predicate device following review by the Orthopedic advisory committee.

Who manufactures CO2 FOR ARTHROSCOPY and where is it made?

CO2 FOR ARTHROSCOPY is manufactured by The Anspach Effort, Inc., located at 1349 S. Killian Dr., Lake Park, FL 33403, United States, and is authorized for distribution in the U.S.

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: CO2 FOR ARTHROSCOPY (K852592) — FDA 510(k) | Innolitics, PDF K852592 CO2 FOR ARTHROSCOPY - 510kdatabase.net, Co2 For Arthroscopy 510 (k) K852592 - FDA.report, Anspach-Effort FDA Filings - FDA.report, Anspach Effort, The FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
The Anspach Effort, Inc.

Sources (1)

  • FDA 510(k) K852592 24 fields · synced Sep 25, 2026