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Sterile Surgical Gown Pack

by Assured Surgical Products, Inc. 510(k)

Active United States

510(k) K914563

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK914563 Date10 Jan 1992ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Sterile Sugical Gown Pack
510(k) Number
FDA Product Code
FYA
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 26 Sep 2026

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

A sterile surgical gown pack is a device intended for use in general and plastic surgery procedures. It provides a sterile barrier to help protect both the patient and surgical team during operative procedures.

The device is supplied sterile and is intended for single-use. It is manufactured by Assured Surgical Products, Inc. and received FDA 510(k) clearance under K914563 on January 10, 1992, with product code FYA.

Other devices from Assured Surgical Products, Inc.

Questions

AI-generated answers, 26 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 sterile surgical gown pack used for?

    The sterile surgical gown pack is intended for use in general and plastic surgery procedures to provide a sterile barrier that helps protect both the patient and surgical team during operative procedures.

  • Is the sterile surgical gown pack supplied sterile and for single-use only?

    Yes, the device is supplied sterile and is intended for single-use, as stated in the device description, to maintain sterility and prevent cross-contamination during surgery.

  • Who manufactures the sterile surgical gown pack and what is its FDA authorization?

    The sterile surgical gown pack is manufactured by Assured Surgical Products, Inc. and received FDA 510(k) clearance under K914563 on January 10, 1992, with product code FYA.