510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192873Substantially Equivalent

SX-One MicroKnife

SONEX HEALTH, Inc, Rochester MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192873 is the FDA 510(k) clearance record for SX-One MicroKnife, a class I device, cleared for Sonex Health, Inc. on under FDA product code LXH (Orthopedic Manual Surgical Instrument). FDA records list 2 510(k) clearances for Sonex Health, Inc., from to . As of , FDA records show one recall naming K192873.

Clearance record

Decision date
Received
(73 days to decision)
Product code
LXH Orthopedic Manual Surgical Instrument
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Sonex Health, Inc. 11 1st Ave. SW, Rochester MN
510(k) summary
Summary PDF
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