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R-Bar Retractor

by Linvatec Corp.

510(k) K942415

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 NumberK942415 Date13 Jun 1994ClearedStatusActive

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The R-Bar Retractor is a surgical instrument classified as a laparoscope for use in general and plastic surgery. It is designed to assist surgeons by providing retraction during medical procedures.

This device is identified under FDA 510(k) clearance K942415. It is manufactured by Linvatec Corp. and is categorized under product code GCJ.

Other devices from Linvatec Corp.

See all devices from Linvatec Corp. →

Questions

AI-generated answers, 27 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 primary function of the R-Bar Retractor?

    The R-Bar Retractor is a surgical instrument classified as a laparoscope. It is specifically designed to assist surgeons by providing necessary retraction during general and plastic surgery procedures.

  • Who is the manufacturer of the R-Bar Retractor?

    The R-Bar Retractor is manufactured by Linvatec Corp., located in Largo, Florida.

  • What is the regulatory status of this device?

    The R-Bar Retractor is identified under FDA 510(k) clearance K942415. It was determined to be substantially equivalent to existing devices through a traditional clearance process.