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Barrier Gynecology Pack Fabric 450

by Surgikos, Inc.

510(k) K780856

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 NumberK780856 Date14 Aug 1978ClearedStatusActive

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  • Withdrawn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
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Barrier Gynecology Pack Fabric 450 is a device intended for use in gynecological procedures, as indicated by its device name and classification under product code KKX. It is designed to provide a protective barrier during surgical interventions in the field of general and plastic surgery, based on the advisory committee assignment.

The device was submitted for regulatory review by Surgikos, Inc. and received a traditional 510(k) clearance (K780856) on August 14, 1978, after being found substantially equivalent to a predicate device. It is manufactured at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, and is identified by the product code KKX.

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Questions

AI-generated answers, 23 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 Barrier Gynecology Pack Fabric 450 used for?

    The Barrier Gynecology Pack Fabric 450 is intended for use in gynecological procedures to provide a protective barrier during surgical interventions, based on its classification under product code KKX and advisory committee assignment for general and plastic surgery.

  • How was the Barrier Gynecology Pack Fabric 450 cleared for market?

    The device received traditional 510(k) clearance (K780856) on August 14, 1978, after being found substantially equivalent to a predicate device, as indicated by its decision code SESE and decision description 'Substantially Equivalent'.

  • Who manufactures the Barrier Gynecology Pack Fabric 450 and where is it made?

    The Barrier Gynecology Pack Fabric 450 is manufactured by Surgikos, Inc. at their facility located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States.