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FDA 510(k)

Strauss Surgical cystoscope, hysteroscope and accessories Instruments

K-Number: K260271 · 2026-03-27

ApplicantAmerican Medical Endoscopy, Inc.
Decision Date2026-03-27
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Strauss Surgical cystoscope, hysteroscope and accessories Instruments is a medical device manufactured by American Medical Endoscopy, Inc.. It received FDA 510(k) clearance on 2026-03-27 under approval number K260271. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

Strauss Surgical cystoscope, hysteroscope and accessories Instruments is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by American Medical Endoscopy, Inc.. The 510(k) number is K260271.

When was Strauss Surgical cystoscope, hysteroscope and accessories Instruments approved by the FDA?

Strauss Surgical cystoscope, hysteroscope and accessories Instruments received FDA 510(k) clearance on 2026-03-27, under approval number K260271.

What company makes Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

Strauss Surgical cystoscope, hysteroscope and accessories Instruments is manufactured by American Medical Endoscopy, Inc..

What is the FDA product code for Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

The FDA product code for Strauss Surgical cystoscope, hysteroscope and accessories Instruments is FAJ.

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Other Devices by American Medical Endoscopy, Inc.

K251652Strauss 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

Related Devices (Code: FAJ)

K160766Ambu USR, Ambu MAmbu A/S K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc. K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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