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510(k) K841115

CHARLES/MCINTYRE GIANT BREAK TABLE by Surgi-Quip Inc.U — Product Code FQO

K841115 is an FDA 510(k) premarket notification submitted by Surgi-Quip Inc.U for the device "CHARLES/MCINTYRE GIANT BREAK TABLE". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Surgi-Quip Inc.U has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
March 15, 1984
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 Surgi-Quip Inc.U

  • K841116 — MOBILE OPHTHALMIC OPERATING TABLE (May 9, 1984)
  • K840004 — WEE BAG O'MERCURY (March 22, 1984)
  • K832887 — ELECTRONIC UNIT (October 4, 1983)
  • K822427 — SELF-CONTAINED MOBILE OPHTHAL. OPER. . (September 14, 1982)
  • K822554 — CEMENT EXTRACTION INSTRUMENTATION (September 14, 1982)
  • K822428 — SURGI-QUIP MICROSCOPE STAND (September 2, 1982)
  • K822426 — MCINTYRE MICROSCOPE STAND (September 2, 1982)

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