510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143068Substantially Equivalent

Medical Monofilament Sensory Screening Toool

Medical Monofilament Manufacturing, Plymouth MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143068 is the FDA 510(k) clearance record for Medical Monofilament Sensory Screening Toool, a class I device, cleared for Medical Monofilament Manufacturing on under FDA product code GXB (Esthesiometer). FDA records list one 510(k) clearance for Medical Monofilament Manufacturing. As of , FDA records show no recalls naming K143068.

Clearance record

Decision date
Received
(82 days to decision)
Product code
GXB Esthesiometer
Regulation
21 CFR 882.1500
Device class
Class I
Review panel
Neurology
Applicant
Medical Monofilament Manufacturing 121 Camelot Dr., Plymouth MA
510(k) summary
Summary PDF
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