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510(k) K954726

STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) by Stryker Endoscopy — Product Code GCX

K954726 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on November 29, 1995. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Stryker Endoscopy has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1995
Date Received
August 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

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  • K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with (February 18, 2026)
  • K260108 — L12 LED Light Source with AIM (February 12, 2026)
  • K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management Sys (January 13, 2026)
  • K253888 — MOLLI 2 System (December 31, 2025)
  • K252010 — SPY Laparoscope (July 24, 2025)
  • K252012 — SPY Cystoscope/Hysteroscope (July 18, 2025)
  • K250544 — Knotilus+ Biocomposite Knotless Anchor (May 23, 2025)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)

FDA data resources