FDA 510(k)

WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION

K-Number: K003402 · 2001-05-01

Decision Date2001-05-01

Product CodeJOL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is Welcon, Inc.. It received FDA 510(k) clearance on 2001-05-01 under 510(k) number K003402. The device is classified under product code JOL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION?

WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION is a medical device that received FDA 510(k) clearance on 2001-05-01. The listed applicant is Welcon, Inc.. The 510(k) number is K003402.

When did WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION receive FDA 510(k) clearance?

WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION received FDA 510(k) clearance on 2001-05-01, under 510(k) number K003402.

Who is the listed applicant for WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION?

The FDA 510(k) record lists Welcon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION?

The FDA product code for WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION is JOL.

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Other records listing Welcon, Inc. as applicant

K973734STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION K971764WELCON HUE-VU URINARY DRAINAGE BAG K912869WOMEN AND INFANT'S DELIVERY PACK K904158ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY K894397WELCON LIGHT HANDLE K830359STERILE CATHERIZATION PROCEDURE TRAYS

View all 8 devices →

Related Devices (Code: JOL)

K051370STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014Baxter Healthcare Corp K000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATIONPrimary Care Solutions, Inc.K000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATIONPrimary Care Solutions, Inc.K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USPAutomatic Liquid Packaging, Inc.K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLEHydrox Laboratories K974759HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLEHydrox Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.