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. · FAJ · Aug 1, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K251652
• 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-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo
• Applicant: American Medical Endoscopy, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Aug 1, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Strauss Surgical Cystoscopes are intended to illuminate and visualize the male urethra, prostate, and bladder for the purpose of performing diagnostic and surgical procedures. Strauss Surgical Hysteroscopes are intended to illuminate and visualize the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Device Story

Rigid endoscopes for urological and gynecological visualization; consist of fiber optic cable for illumination and rigid lens system for image transmission. External light source connects to proximal end; distal objective lens captures images; eyepiece allows direct viewing or connection to camera/monitor system. Used in clinical settings by physicians to perform diagnostic and surgical procedures. Benefits include direct visualization of internal anatomy to guide clinical decision-making and surgical intervention. No working channel present.

Clinical Evidence

No clinical data; bench testing not required due to identical technological characteristics to the predicate device.

Technological Characteristics

Rigid endoscopes; materials include Phynox cobalt-nickel-chromium stainless steel alloy and 304 stainless steel. Fiber optic light transmission; rigid lens image transmission. Direction of view 0°-70°; field of view 67°-80°. Insertion tube diameters 2.9mm and 4mm; length 302mm. No working channel. Reprocessing via manual/automated cleaning, high-level disinfection, and steam sterilization.

Indications for Use

Indicated for illumination and visualization of the male urethra, prostate, bladder, cervical canal, and uterine cavity to perform diagnostic and surgical procedures in urology and gynecology.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Schoelly Cystoscopes/Hysteroscopes and accessories (K150158)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 1, 2025

American Medical Endoscopy, Inc. (DBA Strauss Surgical)
% Shaily Shah
Senior Regulatory Consultant
Medical Device Academy, Inc.
345 Lincoln Hill Road
Shrewsbury, Vermont 05738

Re: K251652

Trade/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-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endoscope, STS-2040-283BA-OLY-endoscope, STS-2040-283CA-OLY-endoscope)

Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FAJ, HIH
Dated: May 29, 2025
Received: May 29, 2025

Dear Shaily Shah:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: The Center for Devices and Radiological Health (CDRH) does not evaluate

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251652 - Shaily Shah
Page 2

information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K251652 - Shaily Shah
Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark J. Antonino -S

Mark J. Antonino, M.S.
Assistant Director
DHT3B: Division of Reproductive, Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Strauss Surgical Cystoscopes & Hysteroscopes
Page 9 of 36

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K251652 | ? |
| Please provide the device trade name(s). | | ? |
| 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-endoscope, STS-2040-283BA-OLY-endoscope) | | |
| Please provide your Indications for Use below. | | ? |
| Strauss Surgical Cystoscopes are intended to illuminate and visualize the male urethra, prostate, and bladder for the purpose of performing diagnostic and surgical procedures. | | |
| Strauss Surgical Hysteroscopes are intended to illuminate and visualize the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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K251652, Page 1 of 2

| 510(k) #: | 510(k) Summary | Prepared on: 2025-07-08 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | American Medical Endoscopy, Inc. (DBA Strauss Surgical) | |
| Applicant Address | 3020 NW 82nd Ave Doral FL 33122 United States | |
| Applicant Contact Telephone | +1.305.436.0599 | |
| Applicant Contact | Mr. Matthew Schwimmer | |
| Applicant Contact Email | [e-mail] | |
| Correspondent Name | Medical Device Academy, Inc. | |
| Correspondent Address | 345 Lincoln Hill Road Shrewsbury VT 05738 United States | |
| Correspondent Contact Telephone | +1.617.774.7542 | |
| Correspondent Contact | Mrs. Shaily Shah | |
| Correspondent Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade 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-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endoscope, STS-2040-283BA-OLY-endoscope) | |
| Common Name | Endoscope and accessories | |
| Classification Name | Cystoscope And Accessories, Flexible/Rigid | |
| Regulation Number | 876.1500 | |
| Product Code(s) | FAJ, HIH | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K150158 | Schoelly Cystoscopes/Hysteroscopes and accessories | FAJ |
| Device Description Summary | | 21 CFR 807.92(a)(4) |

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K251652, Page 2 of 2

The cystoscopes/hysteroscopes described herein are rigid endoscopes for visualizing the urethra, the urinary bladder or uterus, fallopian tube ostium and the cervical canal during the performance of endoscopic procedures in urology or gynecology.

A rigid endoscope consists of a fiber optic cable and sensitive image transmission system with eyepiece.

The fiber optic cable is used to illuminate the site inside the body. The connector for connecting the light guide to the light source is situated at the proximal end of the endoscope. The adapters required to connect the light guide are included in the scope of delivery.

The distal end of the endoscope features an objective lens that captures the image from inside the body. The image is sent through the image transmission system to the eyepiece.

## Intended Use/Indications for Use
**21 CFR 807.92(a)(5)**

Strauss Surgical Cystoscopes are intended to illuminate and visualize the male urethra, prostate, and bladder for the purpose of performing diagnostic and surgical procedures.

Strauss Surgical Hysteroscopes are intended to illuminate and visualize the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

## Indications for Use Comparison
**21 CFR 807.92(a)(5)**

The subject device's indications for use were reworded for consistency but it has equivalent indications for use as the predicate device. This difference does not raise different questions of safety or effectiveness.

## Technological Comparison
**21 CFR 807.92(a)(6)**

The subject and predicate devices have identical technological characteristics. Below is the summary of the technological characteristics:

Light that is created by an external light source is transmitted from the endoscope's light guide connector through the endoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid lens system.

Technical parameters of the Strauss Cystoscopes/Hysteroscopes that characterize the optical view are the Direction of View (0°-70°) and the Field of View (67°-80°).

The image can be displayed by a camera/monitor system which can be connected to the endoscope eyepiece. Models of the Strauss Cystoscopes/Hysteroscopes have the same diameter and length of the insertion tube that is (2.9mm; 4mm/ 302mm). Similar to the predicate device, none of the endoscope models have a working channel.

The subject device endoscope models have outer surfaces mainly made from metal (Phynox cobalt-nickel-chromium stainless steel alloy, 304 stainless steel) and incorporate fiber optics for light transmission and rigid lenses for image transmission.

The subject device requires same reprocessing methods as used for the predicate device. The reprocessing methods include cleaning(manual and automated), high level disinfection and sterilization (steam).

## Non-Clinical and/or Clinical Tests Summary & Conclusions
**21 CFR 807.92(b)**

The subject and predicate devices have identical technological characteristics. Therefore, no performance testing was necessary to demonstrate that the subject device is equivalent to the predicate device in terms of safety and performance.