510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921848Substantially Equivalent

Bfw Wehmerlite IV-a Fiber Optic Surg. Headlight

Alm Surgical Equipment, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921848 is the FDA 510(k) clearance record for BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT, a class II device, cleared for Alm Surgical Equipment, Inc. on under FDA product code FSQ (Light, Surgical, Instrument). FDA records list 10 510(k) clearances for Alm Surgical Equipment, Inc., from to . As of , FDA records show no recalls naming K921848.

Clearance record

Decision date
Received
(167 days to decision)
Product code
FSQ Light, Surgical, Instrument
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Alm Surgical Equipment, Inc. 3323 W. Warner Ave., Santa Ana CA
510(k) summary
Summary
Third party review
No

Clearances, product code FSQ

Trailing 12 months

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

FDA records show no clearances under product code FSQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FSQ, 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