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Surgicla Instrument Kit

by Medical Action Industries Inc.

510(k) K946019

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 NumberK946019 Date20 Mar 1995ClearedStatusActive

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  • Withdrawn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
FRG
FDA applicant
Medical Action Industries, Inc.
Device class
Class II
Regulation
21 CFR Part 880.6850
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Surgicla Instrument Kit is a surgical instrument set classified under the product code FRG, designed for general hospital use. It comprises essential tools for surgical procedures, including hemostatic and cutting instruments, as well as preparatory supplies.

This kit is supplied as a reusable set and is intended for use in sterile surgical environments. It includes items such as a Hemostat Kelly Wire, Forceps, Scissors, and other associated surgical tools. The device holds an FDA 510(k) clearance under K946019, dated March 20, 1995, and is distributed by Medical Action Industries, Inc.

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