Product code GXB— Neurology

FDA has cleared 7 devices under product code GXB between 1976 and 2015, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20151 clearance
• 19941 clearance
• 19871 clearance
• 19801 clearance
• 19781 clearance
• 19771 clearance
• 19761 clearance

• Fred Sammons, Inc.2 clearances
• Ulster Scientific, Inc.1 clearance
• Rowan Products, Inc.1 clearance
• Medical Monofilament Manufacturing1 clearance
• Jablecki, Charles, Dr.1 clearance
• Cadwell Laboratories, Inc.1 clearance

• K143068 — Medical Monofilament Sensory Screening TooolMedical Monofilament Manufacturing·2015-01-14
• K933798 — NU-PREP GELCadwell Laboratories, Inc.·1994-04-22
• K871571 — NEUROTIPS(TM)Ulster Scientific, Inc.·1987-06-18
• K801907 — ALGESIOMETERRowan Products, Inc.·1980-09-16
• K772406 — AESTHESIOMETERFred Sammons, Inc.·1978-01-06
• K771847 — TEMP-TESTERJablecki, Charles, Dr.·1977-11-02
• K761133 — AESTHESIOMETERFred Sammons, Inc.·1976-12-02