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510(k) K951854

LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY by Leonard Medical, Inc. — Product Code FQO

K951854 is an FDA 510(k) premarket notification submitted by Leonard Medical, Inc. for the device "LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY". The FDA issued a decision of Substantially Equivalent on June 21, 1995. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Leonard Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1995
Date Received
April 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

Other clearances by Leonard Medical, Inc.

  • K903536 — SMALL JOINT INSTRUMENTS (SCISSOR HANDLE) (September 6, 1990)
  • K895685 — SMALL JOINT HAND INSTRUMENTS (October 16, 1989)
  • K884308 — MANDIBLE MANIPULATOR (March 31, 1989)
  • K884314 — LEONARD MEDICAL 1.7MM ARTHROSCOPE (March 13, 1989)
  • K873139 — VARUS AND VALGUS LEG HOLDER (September 16, 1987)
  • K864117 — SUPPORT ARM (November 3, 1986)

Other clearances for product code FQO

  • K240598 — Maestro System (REF100) (June 3, 2024)
  • K221410 — Maestro Platform (December 2, 2022)
  • K090136 — STERIS CMAX XLT SURGICAL TABLE (March 20, 2009)
  • K972810 — OPT80 THE TRANSPORTABLE (OPT80) (August 26, 1997)
  • K971988 — ALLEN, ULTRA AND SMART SOCKETS (July 11, 1997)
  • K971307 — AMSCO SURGICAL TABLE (June 27, 1997)
  • K963506 — TENET RADIOLUCENT HAND TABLE (January 9, 1997)
  • K961886 — DRAGER GEMINA WALL-MOUNTED WORKPLACE (July 30, 1996)
  • K961742 — DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (July 26, 1996)
  • K955750 — TELETOM (February 8, 1996)

FDA data resources