510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893380Substantially Equivalent

Qcr System I and Qcr System II

Bremer Mfg. & Tool Co., Inc., Winter Park FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893380 is the FDA 510(k) clearance record for QCR SYSTEM I AND QCR SYSTEM II, a class I device, cleared for Bremer Mfg. & Tool Co., Inc. on under FDA product code LGH (Instrument, Cast Removal, Ac-Powered). FDA records list one 510(k) clearance for Bremer Mfg. & Tool Co., Inc. As of , FDA records show no recalls naming K893380.

Clearance record

Decision date
Received
(199 days to decision)
Product code
LGH Instrument, Cast Removal, Ac-Powered
Regulation
21 CFR 888.5960
Device class
Class I
Review panel
Orthopedic
Applicant
Bremer Mfg. & Tool Co., Inc. 1455 W Fairbanks Ave., Winter Park FL
Third party review
No

Clearances, product code LGH

Trailing 12 months

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

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