Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endosco

FDA 510(k) K251652 · American Medical Endoscopy, Inc.

Substantially Equivalent

510(k) numberK251652

Submission

Device name
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endosco
Applicant
American Medical Endoscopy, Inc.
Doral, FL, US
Received
May 29, 2025
Decision date
August 1, 2025
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
K253020Strauss Surgical Resection InstrumentsHIH · Traditional 06/04/2026SE
K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsFAJ · Traditional 03/27/2026SE

Questions and answers

When was Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endosco cleared by the FDA?

Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endosco (K251652) received a 510(k) decision of Substantially Equivalent on August 1, 2025, 64 days after the submission was received.

What is the product code of K251652?

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