Home / 510(k) Clearances / K992126

510(k) K992126

CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM by Circon Corp. — Product Code GCX

K992126 is an FDA 510(k) premarket notification submitted by Circon Corp. for the device "CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 3, 1999. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Circon Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1999
Date Received
June 23, 1999
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

Other clearances by Circon Corp.

  • K992544 — TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM (October 26, 1999)
  • K981611 — SNAP-N-PEEL INTRODUCERS (July 30, 1998)
  • K980972 — RIGID CULDOSCOPE AND ACCESSORIES (June 12, 1998)
  • K973820 — USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECT (May 12, 1998)
  • K964594 — VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VA (August 15, 1997)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • 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)
  • K954869 — MEDCARE YANKAUER SUCTION DEVICE (January 19, 1996)

FDA data resources