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FDA 510(k)

WELCON LIGHT HANDLE

K-Number: K894397 · 1989-08-10

ApplicantWelcon, Inc.
Decision Date1989-08-10
Product CodeFTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WELCON LIGHT HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Welcon, Inc.. It received FDA 510(k) clearance on 1989-08-10 under 510(k) number K894397. The device is classified under product code FTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELCON LIGHT HANDLE?

WELCON LIGHT HANDLE is a medical device that received FDA 510(k) clearance on 1989-08-10. The listed applicant is Welcon, Inc.. The 510(k) number is K894397.

When did WELCON LIGHT HANDLE receive FDA 510(k) clearance?

WELCON LIGHT HANDLE received FDA 510(k) clearance on 1989-08-10, under 510(k) number K894397.

Who is the listed applicant for WELCON LIGHT HANDLE?

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 LIGHT HANDLE?

The FDA product code for WELCON LIGHT HANDLE is FTA.

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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 PACKK904158ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAYK830359STERILE CATHERIZATION PROCEDURE TRAYS

View all 8 devices →

Related Devices (Code: FTA)

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.

K112133OASYS SURGICAL LIGHT CONTROLLEROasys HealthcareK102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)Image Stream Medical, Inc.K081698MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)Image Stream Medical, Inc.K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERXodus Medical, Inc.K051505SCB/STERIS OR-LIGHT INTERFACE BOXKARL STORZ Endoscopy-America, Inc.K023704KSEA SCB ACC CONTROLKARL STORZ Endoscopy-America, 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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