Strauss Surgical Resection Instruments

FDA 510(k) K253020 · American Medical Endoscopy, Inc.

Substantially Equivalent

510(k) numberK253020

Submission

Device name
Strauss Surgical Resection Instruments
Applicant
American Medical Endoscopy, Inc.
Doral, FL, US
Received
September 19, 2025
Decision date
June 4, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HIH – Hysteroscope (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1690
Specialty
Obstetrics/Gynecology

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K240401ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001…HIH · Traditional Origyn Medical Technology (Hangzhou) Co., Ltd.07/26/2024SE

More from Origyn Medical Technology (Hangzhou) Co., Ltd.

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K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsFAJ · Traditional 03/27/2026SE
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Questions and answers

When was Strauss Surgical Resection Instruments cleared by the FDA?

Strauss Surgical Resection Instruments (K253020) received a 510(k) decision of Substantially Equivalent on June 4, 2026, 258 days after the submission was received.

What is the product code of K253020?

The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.