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FDA 510(k)

CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP

K-Number: K970595 · 1997-10-24

ApplicantCircon Video
Decision Date1997-10-24
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Circon Video. It received FDA 510(k) clearance on 1997-10-24 under 510(k) number K970595. 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 CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP?

CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP is a medical device that received FDA 510(k) clearance on 1997-10-24. The listed applicant is Circon Video. The 510(k) number is K970595.

When did CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP receive FDA 510(k) clearance?

CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP received FDA 510(k) clearance on 1997-10-24, under 510(k) number K970595.

Who is the listed applicant for CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP?

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

What is the FDA product code for CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP?

The FDA product code for CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP is FEN.

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Other records listing Circon Video 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.

K012758URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,K011876DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2K011849MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROSK012929FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735K012951APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPEK012925DUR-8, MODELS DUR-8

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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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