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ENDOFLIP

by Arthocare Corporation

510(k) K013334

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013334 Date13 Dec 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

ENDOFLIP is a medical device classified as a Fastener, Fixation, Nondegradable, Soft Tissue device in the orthopedic specialty. It is designed for use in soft tissue fixation procedures.

ENDOFLIP is supplied by Arthocare Corporation and received FDA 510(k) clearance with number K013334 on 2001-12-13, being determined substantially equivalent. The device is regulated under product code MBI and was reviewed by the Orthopedic panel.

Other devices from Arthocare Corporation

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ENDOFLIP device used for?

    ENDOFLIP is a medical device classified as a Fastener, Fixation, Nondegradable, Soft Tissue device in the orthopedic specialty. It is specifically designed for use in soft tissue fixation procedures.

  • How is the ENDOFLIP device supplied?

    ENDOFLIP is supplied by Arthocare Corporation. The device is manufactured at their facility located at 38 Freemans Way, Harrogate, North Yorkshire, HG3 2QF, United Kingdom.

  • What is the regulatory status of the ENDOFLIP device?

    ENDOFLIP received FDA 510(k) clearance with number K013334 on December 13, 2001, and was determined to be substantially equivalent. It is regulated under product code MBI and was reviewed by the Orthopedic panel.

  • Is the ENDOFLIP device single-use or reusable?

    The device data does not specify whether ENDOFLIP is designed for single-use or multiple uses. For specific usage instructions regarding reprocessing or reuse, please refer to the manufacturer's instructions for use or contact Arthocare Corporation directly.