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FDA 510(k)

OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM

K-Number: K944391 · 1995-02-07

ApplicantSurgitek
Decision Date1995-02-07
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1995-02-07 under 510(k) number K944391. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM?

OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is Surgitek. The 510(k) number is K944391.

When did OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM receive FDA 510(k) clearance?

OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM received FDA 510(k) clearance on 1995-02-07, under 510(k) number K944391.

Who is the listed applicant for OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM?

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

What is the FDA product code for OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM?

The FDA product code for OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM is FEN.

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Other records listing Surgitek 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.

K946296QUADRA-COIL URETERAL STENTK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933260HELICAL STONE/FLATWIRE STONE BASKETSK933261GRASPING FORCEPSK930733URETERAL STENT

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Related Devices (Code: FEN)

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.

K212830CT3000ProSrs MedicalK082701URONIRS, MODEL 2000Urodynamix Technologies, Ltd.K073552LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORYLaborie Medical Technologies, Corp.K001386ACCUSET SENSOR, MODEL 2000Pelvicare, Inc.K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101Medtronic Functional Diagnostics A/SK983325IN-PROBE II URODYNAMIC SYSTEMInfluence, 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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