Device Atlas

Medical Monofilament Sensory Screening Toool

Q: What is the product code of K143068?

The FDA product code is GXB – Esthesiometer, a Class I (low risk) device regulated under 21 CFR 882.1500.

FDA 510(k) K143068 · Medical Monofilament Manufacturing

Substantially Equivalent

510(k) numberK143068

Submission

Device name: Medical Monofilament Sensory Screening Toool
Applicant: Medical Monofilament Manufacturing
Plymouth, MA, US
Received: October 24, 2014
Decision date: January 14, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GXB – Esthesiometer
Device class: Class I (low risk)
Regulation: 21 CFR 882.1500
Specialty: Neurology

Other 510(k)s with product code GXB

510(k)	Device	Applicant	Decision
K933798	Nu-Prep GelGXB · Traditional	Cadwell Laboratories, Inc.	04/22/1994SE
K871571	Neurotips(Tm)GXB · Traditional	Ulster Scientific, Inc.	06/18/1987SE
K801907	AlgesiometerGXB · Traditional	Rowan Products, Inc.	09/16/1980SE
K772406	AesthesiometerGXB · Traditional	Fred Sammons, Inc.	01/06/1978SE
K771847	Temp-TesterGXB · Traditional	Jablecki, Charles, Dr.	11/02/1977SE
K761133	AesthesiometerGXB · Traditional	Fred Sammons, Inc.	12/02/1976SE

Questions and answers

When was Medical Monofilament Sensory Screening Toool cleared by the FDA?

Medical Monofilament Sensory Screening Toool (K143068) received a 510(k) decision of Substantially Equivalent on January 14, 2015, 82 days after the submission was received.

What is the product code of K143068?

The FDA product code is GXB – Esthesiometer, a Class I (low risk) device regulated under 21 CFR 882.1500.