510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902677Substantially Equivalent

Steri-Shield

Biomedical Devices, Inc., Fullerton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902677 is the FDA 510(k) clearance record for STERI-SHIELD, a class II device, cleared for Biomedical Devices, Inc. on under FDA product code FXY (Hood, Surgical). FDA records list 7 510(k) clearances for Biomedical Devices, Inc., from to . As of , FDA records show no recalls naming K902677.

Clearance record

Decision date
Received
(60 days to decision)
Product code
FXY Hood, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Biomedical Devices, Inc. 1501 E. Chapman, Suite 356, Fullerton CA
Third party review
No

Clearances, product code FXY

Trailing 12 months

FDA records hold no clearances under product code FXY in the trailing twelve months.

FDA records show no clearances under product code FXY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260