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FDA 510(k)

SIGNAL GEAR URETHRAL CATHETER ELECTRODE

K-Number: K113771 · 2012-12-13

ApplicantNeurovision Medical Products, Inc.
Decision Date2012-12-13
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SIGNAL GEAR URETHRAL CATHETER ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Neurovision Medical Products, Inc.. It received FDA 510(k) clearance on 2012-12-13 under 510(k) number K113771. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNAL GEAR URETHRAL CATHETER ELECTRODE?

SIGNAL GEAR URETHRAL CATHETER ELECTRODE is a medical device that received FDA 510(k) clearance on 2012-12-13. The listed applicant is Neurovision Medical Products, Inc.. The 510(k) number is K113771.

When did SIGNAL GEAR URETHRAL CATHETER ELECTRODE receive FDA 510(k) clearance?

SIGNAL GEAR URETHRAL CATHETER ELECTRODE received FDA 510(k) clearance on 2012-12-13, under 510(k) number K113771.

Who is the listed applicant for SIGNAL GEAR URETHRAL CATHETER ELECTRODE?

The FDA 510(k) record lists Neurovision Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNAL GEAR URETHRAL CATHETER ELECTRODE?

The FDA product code for SIGNAL GEAR URETHRAL CATHETER ELECTRODE is FAP.

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Other records listing Neurovision Medical Products, Inc. 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.

K130570NEUROVISION MEDICAL MOTION SENSORK130806NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODEK121931NONDISPOSABLE STIMULATING INSTRUMENTSK110989NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODEK110140NEUROVISION NERVE LOCATOR MONITORK110712DRYTOUCH SUCTION STIMULATOR PROBE

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Related Devices (Code: FAP)

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.

K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., Inc.K922476URO-PRO 2000Fiberoptic Sensor Technlogies, 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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