Cortek Cystoscope

FDA 510(k) K000197 · Cortek Endoscopy, Inc.

Substantially Equivalent

510(k) numberK000197

Submission

Device name
Cortek Cystoscope
Applicant
Cortek Endoscopy, Inc.
Palatine, IL, US
Received
January 21, 2000
Decision date
March 3, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FAJ – Cystoscope And Accessories, Flexible/Rigid
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other 510(k)s with product code FAJ

510(k)DeviceApplicantDecision
K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr.…FAJ · Traditional Olympus Winter & Ibe GmbH05/21/2026SE
K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse…FAJ · Traditional Verathon Medical (Canada) Ulc05/11/2026SE
K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm…FAJ · Traditional Strauss Surgical USA04/16/2026SE
K253905PrimeSight UltraView SystemFAJ · Traditional Cogentix Medical, Inc.04/07/2026SE
K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsFAJ · Traditional American Medical Endoscopy, Inc.03/27/2026SE
K253226UV5000W HandleFAJ · Special Uroviu Corporation10/23/2025SE
K251140Zenflow Spring ScopeFAJ · Traditional Zenflow, Inc.09/23/2025SE
K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Special Shanghai AnQing Medical Instrument Co., Ltd.09/15/2025SE
K250797UV5000 HandleFAJ · Traditional Uroviu Corporation09/11/2025SE
K243653KARL STORZ HOPKINS Telescopes for UrologyFAJ · Traditional Karl Storz SE & CO. KG08/13/2025SE

More from Karl Storz SE & CO. KG

510(k)DeviceDecision
K000199Cortek Mini LaparoscopeHET · Traditional 04/13/2000SE
K000198Cortek ArthroscopeHRX · Traditional 04/11/2000SE
K000202Cortek LaparoscopesGCJ · Traditional 03/31/2000SE
K000200Cortek UretheroscopeFGB · Traditional 03/03/2000SE

Questions and answers

When was Cortek Cystoscope cleared by the FDA?

Cortek Cystoscope (K000197) received a 510(k) decision of Substantially Equivalent on March 3, 2000, 42 days after the submission was received.

What is the product code of K000197?

The FDA product code is FAJ – Cystoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.