FDA 510(k)

ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE

K-Number: K030960 · 2003-07-16

Decision Date2003-07-16

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Acmi Corporation. It received FDA 510(k) clearance on 2003-07-16 under 510(k) number K030960. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE?

ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE is a medical device that received FDA 510(k) clearance on 2003-07-16. The listed applicant is Acmi Corporation. The 510(k) number is K030960.

When did ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE receive FDA 510(k) clearance?

ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE received FDA 510(k) clearance on 2003-07-16, under 510(k) number K030960.

Who is the listed applicant for ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE?

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

What is the FDA product code for ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE?

The FDA product code for ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE is FAJ.

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Related Devices (Code: FAJ)

K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,Olympus Winter & Ibe GmbH K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)Verathon Medical (Canada) Ulc K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,Strauss Surgical USA K253905PrimeSight UltraView SystemCogentix Medical, Inc.K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.K253226UV5000W HandleUroviu Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.