KARL STORZ HOPKINS Telescopes for Urology

K243653 · Karl Storz SE & CO. KG · FAJ · Aug 13, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K243653
• Device Name: KARL STORZ HOPKINS Telescopes for Urology
• Applicant: Karl Storz SE & CO. KG
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Aug 13, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Telescopes for adults KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults. Telescopes for adults and pediatrics KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

Device Story

Rigid cystoscope system providing visualization and operative access for urological procedures; includes telescopes, sheaths, obturators, and optical instruments. Operates via external light source; rod lens technology transmits images to physician. Used in clinical settings by urologists. Sheaths provide working channels for instruments and irrigation/aspiration ports; obturators facilitate atraumatic insertion. Compact telescopes feature integrated sheaths/optics. Output is direct visualization of surgical site, enabling diagnostic and therapeutic interventions. Benefits include minimally invasive access to lower urinary tract.

Clinical Evidence

Bench testing only. No clinical data required. Performance validated via ISO 10993 (biocompatibility), ISO 17664/11138/14937/17665/11737/22441 (reprocessing/sterilization), and ISO 8600/IEC 62471/IEC 60601-2-18 (optical/thermal/electrical safety).

Technological Characteristics

Rigid rod lens endoscope. Materials: Stainless steel. Dimensions: 1.9–4mm diameter (telescopes), 6.6–7.9mm (compact). External light source. Sterilization: Steam, STERRAD, V-PRO. Standards: ISO 10993, ISO 8600, IEC 60601-2-18, IEC 62471.

Indications for Use

Indicated for adult and pediatric patients undergoing diagnostic and therapeutic urological procedures of the lower urinary tract, including prostate, bladder, and urethra.

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

• KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPES (K943176)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 13, 2025

Karl Storz SE & Co. KG
Emily Rhiel
Regulatory Affairs Specialist
Dr. Karl-Storz-Straße 34
Tuttlingen, BW 78532
GERMANY

Re: K243653
Trade/Device Name: KARL STORZ HOPKINS Telescopes for Urology
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FAJ
Dated: July 15, 2025
Received: July 15, 2025

Dear Emily Rhiel:

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: 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, 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"

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

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K243653 - Emily Rhiel
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(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.

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

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K243653 - Emily Rhiel
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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 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

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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.

Submission Number (if known)

K243653

Device Name

KARL STORZ HOPKINS Telescopes for Urology

Indications for Use (Describe)

Telescopes for adults
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults.

Telescopes for adults and pediatrics
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

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)

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STORZ

KARL STORZ-ENDOSKOPE

KARL STORZ Premarket Notification

HPOKINS Telescopes for Urology

510(k) Summary K243653

# 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.

| Submitter: | KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen, Germany | |
| --- | --- | --- |
| Contact: | Emily Rhiel Regulatory Affairs Specialist Phone: [phone] Email: [e-mail] | |
| Date of Preparation: | August 6, 2025 | |
| Type of 510(k) Submission: | Traditional | |
| Device Trade name: | KARL STORZ HOPKINS Telescopes for Urology | |
| Regulatory Class: | II | |
| Product Code: | FAJ | |
| Classification Name: | Cystoscope and accessories, Flexible/Rigid (21 CFR Part 876.1500) | |
| Common Name: | Endoscope and accessories | |
| Device Panel: | Gastroenterology & Urology | |
| Predicate Device(s): | K943176 KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPES | |
| Device Description: | The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems, which provide visualization and operative access during urological procedures in adults and pediatrics. Urological devices consist of sheaths, obturators, accessories, and instruments, which are combined into a cystoscope system for diagnostic or therapeutic procedures in the lower urinary tract such as prostate, bladder, and urethra. The sheath provides a working channel for therapeutic instruments, as well as ports for irrigation and aspiration. The obturator is inserted through the sheath for atraumatic insertion to the surgical site, then removed after placement. The telescope is inserted through the sheath for visualization of the surgical site. All instruments subject to this submission are optical instruments, and compatible with telescopes; the optical instruments are only compatible with adult systems. Compact telescopes are all-in-one cystoscopes with built-in sheaths, obturators, and optics, they do not require device compilation for use. Model numbers are provided in the table below. | |
| | Device Type | Model Numbers |
| | HOPKINS Rigid Telescope | 27005AA/BA/BGA/CA/EA/FA, |

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STORZ

KARL STORZ-ENDOSKOPE

KARL STORZ Premarket Notification

HPOKINS Telescopes for Urology

510(k) Summary K243653

| | | | 27017AA/BA, 27018AA/BA/CA, 27020AA/BA/FA, 27301AA/BA, 27324AA, 27325BA |
| --- | --- | --- | --- |
| | | Compact Telescope | 27035BA/BB |
| | | Sheath | 27026A/AA/AB, 27026B/BA/BB, 27026C/CA/CB/CC, 27026DA/DB, 27026U/UA, 27027KL, 27029CN/DN, 27031E/F, 27032K/L/M, 27034A/B |
| | | Obturator | 27026AO/BO/CCO/CO/DO/UO, 27027KO, 27028A/B/BU/C/CN/D, 27029OC/OD, 27031EO/FO, 27032LO/MO/OK, 27034AO/BO |
| | | Optical Instruments | 27072A/BL/BSA/DU/F/MC/S, 27074B |
| | | Accessories | Telescope Bridge: 27025F/G/GA/GF/GFA, 27027NL, 27032F, 27034G, 27047F Instrument Adaptor: 27074SC/SZ, 27093GN/SC, 27094BY |
| Indications for Use: | Telescopes for adults KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults. Telescopes for adults and pediatrics KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics. | | |

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STORZ

KARL STORZ-ENDOSKOPE

KARL STORZ Premarket Notification

HPOKINS Telescopes for Urology

510(k) Summary K243653

| Physical and Technological Characteristics: | | Subject Device Type: Rigid Endoscope | Telescope Predicate: K943176 KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPES |
| --- | --- | --- | --- |
| | Endoscope Type | Rigid, rod lens | Same as subject |
| | Outer Diameter | 1.9 – 4mm Compact telescopes: 6.6 & 7.9mm | Same as subject (No compact telescopes) |
| | Working Length | 11.7 – 30.3cm | 11.7 – 36.3cm |
| | Direction of View | 0 -120° | -3.7 – 120.5° |
| | Field of View | 37.1 - 100° | 36 – 109.3° |
| | Light Source | External | Same as subject |
| | Primary Patient Contacting Material | Stainless steel | Chromium Plated Monel 400 |
| | Cleaning & Sterilization | Cleaning: required Sterilization: • Steam • STERRAD modalities • V-PRO modalities | Cleaning: required Sterilization: • Steam • EtO |
| Non-Clinical Performance Data: | The following non-clinical performance data were provided in support of the substantial equivalence determination. Biocompatibility Evaluation The system complies with the following standards: • ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process • ISO 10993-2: Biological evaluation of medical devices – Part 2: Animal welfare requirements • ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity • ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests skin sensitization • ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity • ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials • ISO 10993-18: Biological evaluation of medical devices – Part 18: Chemical characterization of materials • ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation 2021 Reprocessing Validation The reprocessing data submitted complies with the following standards: • ISO 11138-1: Sterilization of health care products - Biological indicators - Part 1: General requirements | | |

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STORZ KARL STORZ-ENDOSKOPE

KARL STORZ Premarket Notification
HPOKINS Telescopes for Urology
510(k) Summary K243653

| | • ISO 14937: Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices • ISO 17664-1: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices • ISO 17664-2: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices • ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices • ISO 11737-1: Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products • ISO 11737-2: Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process • ISO 11737-3: Sterilization of health care products. Microbiological methods – bacterial endotoxin testing” • ISO 22441: Sterilization of Health Care Products – General Requirements for Characterization of a Sterilization Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices • AAMI TIR12: Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers • ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices. • ANSI / AAMI ST8: “Hospital Steam Sterilizers • ANSI / AAMI ST77: Containment Devices for Reusable Medical Device Sterilization • ANSI / AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities • ANSI / AAMI ST98: Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices |
| --- | --- |
| Bench Performance Testing The bench performance data submitted includes thermal safety and complies with the following standards: • ISO 8600-1: Endoscopes - Medical endoscopes and endotherapy | |

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STORZ KARL STORZ-ENDOSKOPE

KARL STORZ Premarket Notification
HPOKINS Telescopes for Urology
510(k) Summary K243653

| | devices -- Part 1: General requirements • ISO 8600-3: Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics • ISO 8600-5: Optics and photonics — Medical endoscopes and endotherapy devices -Part 5: Determination of optical resolution of endoscopes with optics • IEC 62471: Photobiological safety of lamps and lamp systems • IEC 60601-2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| --- | --- |
| Clinical Performance Data: | Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications. |
| Conclusion: | The conclusions drawn from the non-clinical performance data demonstrates that the subject device is as safe as and as effective as the predicate devices. As such, we conclude that the substantial equivalence of the subject and the predicate devices has been met, and the differences between the subject and the predicate devices do not raise new questions of safety and effectiveness. |