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510(k) K871571

NEUROTIPS(TM) by Ulster Scientific, Inc. — Product Code GXB

K871571 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "NEUROTIPS(TM)". The FDA issued a decision of Substantially Equivalent on June 18, 1987. The device falls under product code GXB (Esthesiometer), a Class I device regulated under 21 CFR 882.1500. Ulster Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1987
Date Received
April 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esthesiometer
Device Class
Class I
Regulation Number
882.1500
Review Panel
NE
Submission Type

Other clearances by Ulster Scientific, Inc.

  • K942620 — FEATHER-TOUCH SINGLE-STICK DEVICE (June 22, 1994)
  • K920562 — UNISTIK (March 27, 1992)
  • K902592 — EPC ELECTRONIC PIPETTING SYSTEM (July 19, 1990)
  • K895890 — AUTOPEN (February 16, 1990)
  • K894474 — THE AUTOLET LITE (August 18, 1989)
  • K885340 — AIR DISPLACEMENT PIPETTE (February 14, 1989)
  • K875354 — UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (February 17, 1988)
  • K871076 — WINPETTE (March 23, 1987)
  • K870078 — ACCUPEN(R) (March 17, 1987)
  • K864761 — USI AUTOJECT INSULIN SYRINGE (December 16, 1986)

Other clearances for product code GXB

  • K143068 — Medical Monofilament Sensory Screening Toool (January 14, 2015)
  • K933798 — NU-PREP GEL (April 22, 1994)
  • K801907 — ALGESIOMETER (September 16, 1980)
  • K772406 — AESTHESIOMETER (January 6, 1978)
  • K771847 — TEMP-TESTER (November 2, 1977)
  • K761133 — AESTHESIOMETER (December 2, 1976)

FDA data resources