510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K921402Substantially Equivalent

Surgical Instrument, Disposable

Macro Medical, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921402 is the FDA 510(k) clearance record for SURGICAL INSTRUMENT, DISPOSABLE, a class I device, cleared for Macro Medical, Inc. on under FDA product code LXH (Orthopedic Manual Surgical Instrument). FDA records list one 510(k) clearance for Macro Medical, Inc. As of , FDA records show no recalls naming K921402.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LXH Orthopedic Manual Surgical Instrument
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Macro Medical, Inc. 5179 St. Imier Dr., Suite 100, Minneapolis MN
510(k) summary
Statement
Third party review
No

Clearances, product code LXH

Trailing 12 months

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

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