510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K911238Substantially Equivalent

Tahoe Suction Irrigator

Tahoe Pro Instruments, So. Lake Tahoe CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911238 is the FDA 510(k) clearance record for TAHOE SUCTION IRRIGATOR, a class II device, cleared for Tahoe Pro Instruments on under FDA product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered). FDA records list one 510(k) clearance for Tahoe Pro Instruments. As of , FDA records show no recalls naming K911238.

Clearance record

Decision date
Received
(618 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
Tahoe Pro Instruments P.O. Box 612617, So. Lake Tahoe CA
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