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FDA 510(k)

ENDOTEK ULTRA SYSTEM

K-Number: K920451 · 1992-09-17

ApplicantSurgitek
Decision Date1992-09-17
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOTEK ULTRA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1992-09-17 under 510(k) number K920451. 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 ENDOTEK ULTRA SYSTEM?

ENDOTEK ULTRA SYSTEM is a medical device that received FDA 510(k) clearance on 1992-09-17. The listed applicant is Surgitek. The 510(k) number is K920451.

When did ENDOTEK ULTRA SYSTEM receive FDA 510(k) clearance?

ENDOTEK ULTRA SYSTEM received FDA 510(k) clearance on 1992-09-17, under 510(k) number K920451.

Who is the listed applicant for ENDOTEK ULTRA SYSTEM?

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

What is the FDA product code for ENDOTEK ULTRA SYSTEM?

The FDA product code for ENDOTEK ULTRA SYSTEM is FAP.

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Other records listing Surgitek 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.

K946296QUADRA-COIL URETERAL STENTK944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933261GRASPING FORCEPSK933260HELICAL STONE/FLATWIRE STONE BASKETS

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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.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., 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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