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FDA 510(k)

SURGITEK (R) UROFLOW SYSTEM

K-Number: K883274 · 1989-02-08

ApplicantMedical Engineering Corp.
Decision Date1989-02-08
Product CodeFFG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITEK (R) UROFLOW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering Corp.. It received FDA 510(k) clearance on 1989-02-08 under 510(k) number K883274. The device is classified under product code FFG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK (R) UROFLOW SYSTEM?

SURGITEK (R) UROFLOW SYSTEM is a medical device that received FDA 510(k) clearance on 1989-02-08. The listed applicant is Medical Engineering Corp.. The 510(k) number is K883274.

When did SURGITEK (R) UROFLOW SYSTEM receive FDA 510(k) clearance?

SURGITEK (R) UROFLOW SYSTEM received FDA 510(k) clearance on 1989-02-08, under 510(k) number K883274.

Who is the listed applicant for SURGITEK (R) UROFLOW SYSTEM?

The FDA 510(k) record lists Medical Engineering Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGITEK (R) UROFLOW SYSTEM?

The FDA product code for SURGITEK (R) UROFLOW SYSTEM is FFG.

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Other records listing Medical Engineering Corp. 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.

K934141STAND ALONE CYSTOMETROGRAMK905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENTK903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDERK902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SETK884746SURGITEK FLAT T-SPANK881736SURGITEK CO2 DELIVERY SYSTEM

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Related Devices (Code: FFG)

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.

K893827PEAK FLOW RATE METERLaytech Medical Co.K850169ERIS URO-DIAGNOSTIC SYSTEMEris Medical TechnologyK8443381URO-LOG HOME DIAGNOSTIC PACKEpcom Medical Systems, Inc.K843441URINARY DRAINAGE CONTAINER 2012-WITHVital Metrics, Inc.K843442URINARY DRAINAGE CONTAINER 2013 WITHVital Metrics, Inc.K844030ACCUMETER ELECTRONIC URINEMETER SYSTEMTravenol Laboratories, S.A.

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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