Hood, Operating, Surgical

FDA 510(k) K904969 · Chicago Assoc. For Retarded Citizens

Substantially Equivalent

510(k) numberK904969

Submission

Device name
Hood, Operating, Surgical
Applicant
Chicago Assoc. For Retarded Citizens
Chicago, IL, US
Received
November 5, 1990
Decision date
December 12, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FXY – Hood, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4040
Specialty
General, Plastic Surgery

Other 510(k)s with product code FXY

510(k)DeviceApplicantDecision
K222214ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)FXY · Traditional Thi Total Healthcare Innovation GmbH10/17/2023SE
K200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical…FXY · Traditional Stryker Corporation03/21/2020SE
K140588Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensFXY · Special Stryker Corporation06/26/2014SE
K904276Disposable Beard CoverFXY · Traditional Anago, Inc.11/21/1990SE
K903533Steri-ShieldFXY · Traditional Biomedical Devices, Inc.10/19/1990SE
K902677Steri-ShieldFXY · Traditional Biomedical Devices, Inc.08/17/1990SE
K880431Caretex Surgeon's HoodsFXY · Traditional James River Corp.02/24/1988SE
K770261Hood, Clarion SurgeonsFXY · Traditional Sherwood Medical Industries03/01/1977SE
K770257Hood & Beard Cover, Clarion Surgeon'sFXY · Traditional Sherwood Medical Industries02/25/1977SE
K761070P.S.M. Surgical HoodFXY · Traditional The Owenby Co.12/30/1976SE

Questions and answers

When was Hood, Operating, Surgical cleared by the FDA?

Hood, Operating, Surgical (K904969) received a 510(k) decision of Substantially Equivalent on December 12, 1990, 37 days after the submission was received.

What is the product code of K904969?

The FDA product code is FXY – Hood, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.