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FDA 510(k)

ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY

K-Number: K904158 · 1990-11-29

ApplicantWelcon, Inc.
Decision Date1990-11-29
Product CodeFCM
Advisory CommitteeGU
DecisionUnknown

Device Summary

ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Welcon, Inc.. It received FDA 510(k) clearance on 1990-11-29 under 510(k) number K904158. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY?

ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Welcon, Inc.. The 510(k) number is K904158.

When did ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY receive FDA 510(k) clearance?

ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY received FDA 510(k) clearance on 1990-11-29, under 510(k) number K904158.

Who is the listed applicant for ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY?

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 ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY?

The FDA product code for ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY is FCM.

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Other records listing Welcon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONK973734STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATIONK971764WELCON HUE-VU URINARY DRAINAGE BAGK912869WOMEN AND INFANT'S DELIVERY PACKK894397WELCON LIGHT HANDLEK830359STERILE CATHERIZATION PROCEDURE TRAYS

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Related Devices (Code: FCM)

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K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec LimitedK223821Self-Cath Closed SystemColoplastK082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLCK070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, Inc.

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.

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