510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003402Substantially Equivalent

Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device Irrigation

Welcon, Inc., Ayer MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003402 is the FDA 510(k) clearance record for WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION, a class II device, cleared for Welcon, Inc. on under FDA product code JOL (Catheter And Tip, Suction). FDA records list 8 510(k) clearances for Welcon, Inc., from to . As of , FDA records show no recalls naming K003402.

Clearance record

Decision date
Received
(181 days to decision)
Product code
JOL Catheter And Tip, Suction
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Welcon, Inc. 5 Whitcomb Ave., Ayer MA
510(k) summary
Summary
Third party review
No

Clearances, product code JOL

Trailing 12 months

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

FDA records show no clearances under product code JOL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOL, 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