510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992126Substantially Equivalent

Circon Surgiflex Wave Tsunami Suction-Irrigation System

Circon Corp., Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992126 is the FDA 510(k) clearance record for CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM, a class II device, cleared for Circon Corp. on under FDA product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered). FDA records list 6 510(k) clearances for Circon Corp., from to . As of , FDA records show no recalls naming K992126.

Clearance record

Decision date
Received
(41 days to decision)
Product code
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Circon Corp. 6500 Hollister Ave., Santa Barbara CA
510(k) summary
Summary
Third party review
No

Clearances, product code GCX

Trailing 12 months

FDA records hold no clearances under product code GCX in the trailing twelve months.

FDA records show no clearances under product code GCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260