510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K761133Substantially Equivalent

Aesthesiometer

Fred Sammons, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K761133 is the FDA 510(k) clearance record for AESTHESIOMETER, a class I device, cleared for Fred Sammons, Inc. on under FDA product code GXB (Esthesiometer). FDA records list 278 510(k) clearances for Fred Sammons, Inc., from to . As of , FDA records show no recalls naming K761133.

Clearance record

Decision date
Received
(13 days to decision)
Product code
GXB Esthesiometer
Regulation
21 CFR 882.1500
Device class
Class I
Review panel
Neurology
Applicant
Fred Sammons, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GXB

Trailing 12 months

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

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