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FDA 510(k)

SCHUSTER DISPOSABLE BALLOON PROBE

K-Number: K931175 · 1994-04-01

ApplicantSandhill Scientific, Inc.
Decision Date1994-04-01
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SCHUSTER DISPOSABLE BALLOON PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Sandhill Scientific, Inc.. It received FDA 510(k) clearance on 1994-04-01 under 510(k) number K931175. 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 SCHUSTER DISPOSABLE BALLOON PROBE?

SCHUSTER DISPOSABLE BALLOON PROBE is a medical device that received FDA 510(k) clearance on 1994-04-01. The listed applicant is Sandhill Scientific, Inc.. The 510(k) number is K931175.

When did SCHUSTER DISPOSABLE BALLOON PROBE receive FDA 510(k) clearance?

SCHUSTER DISPOSABLE BALLOON PROBE received FDA 510(k) clearance on 1994-04-01, under 510(k) number K931175.

Who is the listed applicant for SCHUSTER DISPOSABLE BALLOON PROBE?

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

What is the FDA product code for SCHUSTER DISPOSABLE BALLOON PROBE?

The FDA product code for SCHUSTER DISPOSABLE BALLOON PROBE is FAP.

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Other records listing Sandhill Scientific, 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.

K111013ACEMK012232INSIGHT, MODEL S980000K013951SANDHILL SCIENTIFIC PEDIATEC PH PROBEK002427SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026K990441INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300K984444INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000

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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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.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.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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