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Steri-Shield

by Biomedical Devices, Inc. 2 variants

510(k) K902677

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 NumberK902677 Date17 Aug 1990ClearedStatusActive

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  • Withdrawn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
FXY
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Steri-Shield is a surgical hood device classified under device class 2 with product code FXY. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA on August 17, 1990, under K902677.

The device is authorized for use in general and plastic surgery settings. It is manufactured by Biomedical Devices, Inc. and is registered under multiple FEI and registration numbers as specified in the openFDA data, with regulation number 878.4040 governing its classification.

Other devices from Bio-Medical Devices, Inc.

See all devices from Bio-Medical Devices, Inc. →

Questions

AI-generated answers, 24 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 Steri-Shield device used for?

    The Steri-Shield is a surgical hood device authorized for use in general and plastic surgery settings, as indicated in its FDA 510(k) clearance documentation.

  • When was the Steri-Shield cleared by the FDA?

    The Steri-Shield received traditional 510(k) clearance from the FDA on August 17, 1990, under submission number K902677, based on substantial equivalence to a predicate device.

  • What regulatory classification applies to the Steri-Shield?

    The Steri-Shield is classified as a class II medical device under regulation number 878.4040, with product code FXY, and is grouped under the medical specialty of general and plastic surgery.