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510(k) K903533

STERI-SHIELD by Biomedical Devices, Inc. — Product Code FXY

K903533 is an FDA 510(k) premarket notification submitted by Biomedical Devices, Inc. for the device "STERI-SHIELD". The FDA issued a decision of Substantially Equivalent on October 19, 1990. The device falls under product code FXY (Hood, Surgical), a Class II device regulated under 21 CFR 878.4040. Biomedical Devices, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1990
Date Received
August 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hood, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Biomedical Devices, Inc.

  • K955439 — THE REEL THING (MODIFICATION) (December 26, 1995)
  • K931847 — BIO-PREP CEMENT RESTRICTOR (June 28, 1994)
  • K931846 — BIO-PREP (January 21, 1994)
  • K925982 — BMD AIR/OXYGEN BLENDER (October 7, 1993)
  • K902677 — STERI-SHIELD (August 17, 1990)
  • K830605 — PUMP PALL AMBULATORY INSULIN INFUSION (March 31, 1983)

Other clearances for product code FXY

  • K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) (October 17, 2023)
  • K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgi (March 21, 2020)
  • K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS (June 26, 2014)
  • K904969 — HOOD, OPERATING, SURGICAL (December 12, 1990)
  • K904276 — DISPOSABLE BEARD COVER (November 21, 1990)
  • K902677 — STERI-SHIELD (August 17, 1990)
  • K880431 — CARETEX SURGEON'S HOODS (February 24, 1988)
  • K770261 — HOOD, CLARION SURGEONS (March 1, 1977)
  • K770257 — HOOD & BEARD COVER, CLARION SURGEON'S (February 25, 1977)
  • K761070 — P.S.M. SURGICAL HOOD (December 30, 1976)

FDA data resources