Strauss Surgical cystoscope, hysteroscope and accessories Instruments

K260271 · American Medical Endoscopy, Inc. · FAJ · Mar 27, 2026 · Gastroenterology, Urology

Device Facts

Record IDK260271
Device NameStrauss Surgical cystoscope, hysteroscope and accessories Instruments
ApplicantAmerican Medical Endoscopy, Inc.
Product CodeFAJ · Gastroenterology, Urology
Decision DateMar 27, 2026
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.1500
Device ClassClass 2
AttributesTherapeutic

Intended Use

Endoscopes: Cystoscopes/Hysteroscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Cystoscopes/Hysteroscopes are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site. Urology Instruments: The Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The instruments are intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

Device Story

Rigid or flexible endoscopic instruments (cystoscopes/hysteroscopes) used for direct visualization and surgical manipulation in urology and gynecology; operated by surgeons in clinical settings. System includes telescope (optical system), illumination source, and working channels for accessory instruments (biopsy, stone removal, stent placement). Sheaths provide access conduits with irrigation/drainage; obturators facilitate atraumatic insertion; bridges connect components and provide ports; Albarran deflectors allow mechanical angulation of accessories. Optical forceps enable visualization during tissue manipulation. Device provides direct optical view to the surgeon to guide diagnostic and therapeutic procedures, facilitating minimally invasive access via natural orifices.

Clinical Evidence

Bench testing only. Evaluation included mechanical, optical, and illumination performance verification. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity). Cleaning and steam sterilization validated to 10^-6 sterility assurance level. Risk analysis conducted per ISO 14971. Conformance to ISO 8600 series and IEC 60601-2-18 standards demonstrated.

Technological Characteristics

Rigid/flexible endoscopes; working length 269-302mm; outer diameter 2.7-4.0mm; light source Xenon or LED; deflection 0°-70°. Components: telescope, sheath, obturator, bridge, Albarran deflector, optical forceps. Sterilization: steam. Standards: ISO 10993-1, ISO 14971, ISO 8600-1/3/4/5/6, IEC 60601-2-18.

Indications for Use

Indicated for patients undergoing endoscopic diagnostic and therapeutic surgical procedures in general urology and gynecology, specifically for visualization and manipulation of anatomy in the lower urinary tract and gynecological sites via natural orifices.

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

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION March 27, 2026 American Medical Endoscopy, Inc. % Shaily Shah Senior Regulatory Consultant Shaily Shah 345 Lincoln Hill Rd. Shrewsbury, Vermont 05788 Re: K260271 Trade/Device Name: Strauss Surgical cystoscope, hysteroscope and accessories Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ, HIH Dated: January 28, 2026 Received: January 28, 2026 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 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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260271 - Shaily Shah Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (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 Management System Regulation (QMSR) (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. 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 {2} K260271 - Shaily Shah Page 3 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mark R. Kreitz -S for 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K260271 Device Name Strauss Surgical cystoscope, hysteroscope and accessories Instruments Indications for Use (Describe) Endoscopes: Cystoscopes/Hysteroscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Cystoscopes/Hysteroscopes are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site. Urology Instruments: The Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The instruments are intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 {4} K260271, Page 1 of 3 | 510(k) #: | 510(k) Summary | Prepared on: 2026-01-28 | | --- | --- | --- | | Contact Details | | 21 CFR 807.92(a)(1) | | Applicant Name | American Medical Endoscopy, Inc. | | | 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 | kip@endoscopia.com | | | Correspondent Name | 345 Lincoln Hill Rd | | | Correspondent Address | null Shrewsbury VT 05788 United States | | | Correspondent Contact Telephone | +1.617.774.7542 | | | Correspondent Contact | Mrs. Shaily Shah | | | Correspondent Contact Email | shaily@fdaestar.com | | | Device Name | | 21 CFR 807.92(a)(2) | | Device Trade Name | Strauss Surgical cystoscope/hysteroscope and accessories Instruments | | | 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 | | K171336 | Cystoscope 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 Sheath | FAJ | | Device Description Summary | | 21 CFR 807.92(a)(4) | | Cystoscopes, Hysteroscopes and Accessories are composed of cystoscopes, hysteroscopes and cystoscopic accessories, which provide the user with the means for endoscopic diagnostic and therapeutic procedures. Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate. The subject device includes the following components: • Cystoscope /Hysteroscopes: A rigid or flexible endoscopic instrument designed for direct visualization of the urethra and urinary bladder. It consists of an optical system (telescope), an illumination source, and working channels that allow the introduction of instruments for diagnostic and therapeutic procedures such as biopsies, stone removal, or stent placement. | | | {5} K260271, Page 2 of 3 - Sheaths – Outer tubular component that serves as the access conduit during cystoscopy. It provides irrigation and drainage channels to maintain clear visualization, and allows for the introduction of instruments into the bladder. The sheath connects with the bridge and obturator to form the working assembly. - Obturators – A smooth-tipped guiding element inserted through the cystoscopic sheath to facilitate atraumatic insertion into the urethra. Once access is achieved, the obturator is removed, allowing the sheath to remain in place for the procedure. - Visual Obturator – A specialized obturator with an optical channel that accommodates the telescope, enabling direct visualization during insertion. It ensures safe, controlled advancement of the sheath under continuous endoscopic view. - Bridge – An intermediate component that connects the cystoscopic sheath to the telescope and accessory instruments. It provides ports for irrigation and instrument entry, enabling controlled manipulation during diagnostic and therapeutic procedures. - Albarran deflectors: A built-in mechanical deflection mechanism located in the bridge or sheath assembly. It allows precise angulation and control of accessory instruments, such as guidewires or forceps, facilitating access to the ureteral orifices. - Optical Forceps: Endoscopic grasping instruments equipped with an integrated optical channel for direct visualization during tissue manipulation or foreign body retrieval. They enable precise control and visualization through the telescope. ## Intended Use/Indications for Use **21 CFR 807.92(a)(5)** **Endoscopes:** Cystoscopes/Hysteroscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Cystoscopes/Hysteroscopes are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site. **Urology Instruments:** The Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The instruments are intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site. ## Indications for Use Comparison **21 CFR 807.92(a)(5)** The subject and predicate devices have the same intended use and the same indications for use. ## Technological Comparison **21 CFR 807.92(a)(6)** The subject and predicate devices are identical. The only differences are in the sponsor name. The following technological characteristics are identical: Working length (± 0.5mm) - 269mm – 302mm Outer diameter (± 0.2mm) - 2.7mm – 4.0mm Distal Tip (Outer Diameter) - 2.7mm – 4.0mm Light Source - Xenon, LED Deflection (°) - 0° - 70° ## Non-Clinical and/or Clinical Tests Summary & Conclusions **21 CFR 807.92(b)** Below is the summary of non-clinical tests performed: {6} K260271, Page 3 of 3 - Bench testing was conducted to verify the performance of the Cystoscopes, Hysteroscopes, and Accessories. Design verification testing was conducted to evaluate the mechanical, optical, and illumination performance. - Below Biocompatibility testing was performed according to ISO 10993-1: Cytotoxicity Test- ISO 1993-5 - The cleaning instructions were also validated. The Strauss Surgical Cystoscopes, Hysteroscopes, and Accessories has been validated for manual and automated cleaning as well as steam sterilization to provide a sterility assurance of 10-6. - The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971. The subject devices demonstrate conformance with the following recognized standards and guidances: - 510(k) submission guidance for Hysteroscopes and Gynecology Laparoscopes; - IEC 60601-2-18, Sec. 201.11.1.2.2 - ISO 8600-1; - ISO 8600-3; - ISO 8600-4; - ISO 8600-5; - ISO 8600-6. Results of all non-clinical testing demonstrates that the subject device is as safe, as effective and performs same as the predicate device.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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