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FDA 510(k)

UROTRACT I

K-Number: K955019 · 1995-12-06

ApplicantDornier Medtech America, Inc.
Decision Date1995-12-06
Product CodeKQS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROTRACT I is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 1995-12-06 under 510(k) number K955019. The device is classified under product code KQS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROTRACT I?

UROTRACT I is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K955019.

When did UROTRACT I receive FDA 510(k) clearance?

UROTRACT I received FDA 510(k) clearance on 1995-12-06, under 510(k) number K955019.

Who is the listed applicant for UROTRACT I?

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

What is the FDA product code for UROTRACT I?

The FDA product code for UROTRACT I is KQS.

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Other records listing Dornier Medtech America, Inc. as applicant

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Related Devices (Code: KQS)

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.

K872022UROVIEWOec-Diasonics, Inc.K864846RADIOGRAPHIC - LEG SECTIONAmerican Sterilizer Co.K860040HYDRAJUST III UROLOGICAL TABLEMallinckrodt Group, Inc.K852127AMSCO URO-ENDO MOBILE TABLEAmerican Sterilizer Co.K801723UR 150-UR 150TSiemens Corp.K791699HYDRADJUST II UROLOGICAL TABLESybron Corp.

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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