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510(k) K926237

O'BRIEN GONIOMETER by Sgarlato Laboratories, Inc. — Product Code KQW

K926237 is an FDA 510(k) premarket notification submitted by Sgarlato Laboratories, Inc. for the device "O'BRIEN GONIOMETER". The FDA issued a decision of Substantially Equivalent on August 2, 1993. The device falls under product code KQW (Goniometer, Nonpowered), a Class I device regulated under 21 CFR 888.1520. Sgarlato Laboratories, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1993
Date Received
December 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Goniometer, Nonpowered
Device Class
Class I
Regulation Number
888.1520
Review Panel
NE
Submission Type

Other clearances by Sgarlato Laboratories, Inc.

  • K043204 — SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP (March 30, 2005)
  • K990101 — PAIN CONTROL INFUSION PUMP (March 19, 1999)
  • K982931 — THREADED FIXATION PIN (October 21, 1998)
  • K926262 — FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE (January 26, 1994)
  • K922292 — LUNDEEN SUBTALAR PEG IMPLANT (October 23, 1992)
  • K905795 — SGARLATO FLEXIBLE HINGE TOE IMPLANT (May 29, 1991)
  • K884739 — SGARLATO LESSER TOE IMPLANT (May 18, 1989)

Other clearances for product code KQW

  • K901744 — DOBBHOFF(R) RETRIEVAL FORCEPS (July 3, 1990)
  • K870767 — THE (CROM) TESTER (March 17, 1987)
  • K850082 — HAND HELD GONIOMETER (April 4, 1985)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K812778 — THE TELOS EQUIPMENT (December 8, 1981)
  • K810441 — UNIVERSAL GONIMETER (February 27, 1981)
  • K801717 — BK-7511 BRASS GONIOMETER (August 4, 1980)
  • K801718 — BK-7513 STAINLESS STEEL GONIOMETER (August 4, 1980)
  • K801715 — BK-7497 BULB DYNAMOMETER (August 4, 1980)
  • K801716 — BK-7505 RADIOPAQUE GONIOMETER, 8 (August 4, 1980)

FDA data resources