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FDA 510(k)

RUSCH URODYNAMIC RECTAL BALLOON CATHETER

K-Number: K952573 · 1995-06-15

ApplicantRusch Intl.
Decision Date1995-06-15
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RUSCH URODYNAMIC RECTAL BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 1995-06-15 under 510(k) number K952573. 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 RUSCH URODYNAMIC RECTAL BALLOON CATHETER?

RUSCH URODYNAMIC RECTAL BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1995-06-15. The listed applicant is Rusch Intl.. The 510(k) number is K952573.

When did RUSCH URODYNAMIC RECTAL BALLOON CATHETER receive FDA 510(k) clearance?

RUSCH URODYNAMIC RECTAL BALLOON CATHETER received FDA 510(k) clearance on 1995-06-15, under 510(k) number K952573.

Who is the listed applicant for RUSCH URODYNAMIC RECTAL BALLOON CATHETER?

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

What is the FDA product code for RUSCH URODYNAMIC RECTAL BALLOON CATHETER?

The FDA product code for RUSCH URODYNAMIC RECTAL BALLOON CATHETER is FEN.

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Other records listing Rusch Intl. 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.

K033023INTERMITTENT URETHRAL CATHETERSK030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEMK023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETERK023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESSK023964RUSCH MICROLARYNGEAL TUBEK021540RUSCH EDGAR TUBE

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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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