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FDA 510(k)

SURGITEK CO2 DELIVERY SYSTEM

K-Number: K881736 · 1988-08-11

ApplicantMedical Engineering Corp.
Decision Date1988-08-11
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITEK CO2 DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering Corp.. It received FDA 510(k) clearance on 1988-08-11 under 510(k) number K881736. 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 SURGITEK CO2 DELIVERY SYSTEM?

SURGITEK CO2 DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1988-08-11. The listed applicant is Medical Engineering Corp.. The 510(k) number is K881736.

When did SURGITEK CO2 DELIVERY SYSTEM receive FDA 510(k) clearance?

SURGITEK CO2 DELIVERY SYSTEM received FDA 510(k) clearance on 1988-08-11, under 510(k) number K881736.

Who is the listed applicant for SURGITEK CO2 DELIVERY SYSTEM?

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

What is the FDA product code for SURGITEK CO2 DELIVERY SYSTEM?

The FDA product code for SURGITEK CO2 DELIVERY SYSTEM is FAP.

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Other records listing Medical Engineering Corp. 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.

K934141STAND ALONE CYSTOMETROGRAMK905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENTK903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDERK902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SETK884746SURGITEK FLAT T-SPANK883274SURGITEK (R) UROFLOW SYSTEM

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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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