Cleared Traditional

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-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo

K251652 · American Medical Endoscopy, Inc. · Obstetrics & Gynecology

Aug 2025

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K251652 is an FDA 510(k) clearance for the 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-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo, a Cystoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FAJ), submitted by American Medical Endoscopy, Inc. (Doral, US). The FDA issued a Cleared decision on August 1, 2025, 64 days after receiving the submission on May 29, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K251652 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2025
Decision Date	August 01, 2025
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	FAJ — Cystoscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	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).