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FDA 510(k)

URODYNAMIC ANALYSIS MODULE

K-Number: K963330 · 1997-04-03

ApplicantSynectics Medical, Inc.
Decision Date1997-04-03
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URODYNAMIC ANALYSIS MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Synectics Medical, Inc.. It received FDA 510(k) clearance on 1997-04-03 under 510(k) number K963330. 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 URODYNAMIC ANALYSIS MODULE?

URODYNAMIC ANALYSIS MODULE is a medical device that received FDA 510(k) clearance on 1997-04-03. The listed applicant is Synectics Medical, Inc.. The 510(k) number is K963330.

When did URODYNAMIC ANALYSIS MODULE receive FDA 510(k) clearance?

URODYNAMIC ANALYSIS MODULE received FDA 510(k) clearance on 1997-04-03, under 510(k) number K963330.

Who is the listed applicant for URODYNAMIC ANALYSIS MODULE?

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

What is the FDA product code for URODYNAMIC ANALYSIS MODULE?

The FDA product code for URODYNAMIC ANALYSIS MODULE is FAP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Synectics Medical, 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.

K961070ESOPHAGEAL MANOMETRY ANALYSIS MODULEK951442FLOLABK946322POLYGRAM SOFTWAREK942445SYNERGY II

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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, 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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