Decision Date2000-03-03
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
CORTEK CYSTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Cortek Endoscopy, Inc.. It received FDA 510(k) clearance on 2000-03-03 under 510(k) number K000197. 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 CORTEK CYSTOSCOPE?
CORTEK CYSTOSCOPE is a medical device that received FDA 510(k) clearance on 2000-03-03. The listed applicant is Cortek Endoscopy, Inc.. The 510(k) number is K000197.
When did CORTEK CYSTOSCOPE receive FDA 510(k) clearance?
CORTEK CYSTOSCOPE received FDA 510(k) clearance on 2000-03-03, under 510(k) number K000197.
Who is the listed applicant for CORTEK CYSTOSCOPE?
The FDA 510(k) record lists Cortek Endoscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CORTEK CYSTOSCOPE?
The FDA product code for CORTEK CYSTOSCOPE is FAJ.
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.
Other records listing Cortek Endoscopy, 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.
Related Devices (Code: FAJ)
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.
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 GmbHK253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)Verathon Medical (Canada) UlcK253892Strauss 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 USAK253905PrimeSight UltraView SystemCogentix Medical, Inc.K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.K253226UV5000W HandleUroviu Corporation
Official Source
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