Omni Cystoscope

FDA 510(k) K922320 · Expanded Optics, Inc.

Substantially Equivalent

510(k) numberK922320

Submission

Device name
Omni Cystoscope
Applicant
Expanded Optics, Inc.
Westminster, CA, US
Received
May 18, 1992
Decision date
January 13, 1993
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
K922321Omni ArthroscopeHRX · Traditional 08/03/1993SE
K922319Omni LaparoscopeGCJ · Traditional 04/23/1993SE
K894570Universal Light CableLDQ · Traditional 10/13/1989SE

Questions and answers

When was Omni Cystoscope cleared by the FDA?

Omni Cystoscope (K922320) received a 510(k) decision of Substantially Equivalent on January 13, 1993, 240 days after the submission was received.

What is the product code of K922320?

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