Medivision Cystoscope

FDA 510(k) K982620 · Medivision Scope Service Center, Inc.

Substantially Equivalent

510(k) numberK982620

Submission

Device name
Medivision Cystoscope
Applicant
Medivision Scope Service Center, Inc.
Anaheim, CA, US
Received
July 27, 1998
Decision date
September 30, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
K984434Medivision LaparoscopeGCJ · Traditional 03/17/1999SE
K982659Medivision HysteroscopeHIH · Traditional 10/07/1998SE
K971996Medivision ArthroscopHRX · Traditional 07/31/1997SE
K971995Medivision SinoscopeEOB · Traditional 06/26/1997SE

Questions and answers

When was Medivision Cystoscope cleared by the FDA?

Medivision Cystoscope (K982620) received a 510(k) decision of Substantially Equivalent on September 30, 1998, 65 days after the submission was received.

What is the product code of K982620?

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