UNIDRIVE Select System

K260884 · Karl Storz SE & CO. KG · GCJ · Sep 1, 2026 · Gastroenterology, Urology

Device Facts

• Record ID: K260884
• Device Name: UNIDRIVE Select System
• Applicant: Karl Storz SE & CO. KG
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 1, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The UNIDRIVE Select System is intended for cutting and removal of enucleated prostrate tissue from the lower urinary tract in endoscopic interventions.

Device Story

Motorized surgical system for urological tissue morcellation; comprises UNIDRIVE Select motor control unit, wired/wireless footswitches, DrillCut-X II Morcellator Handpiece, and morcellator blades. Input: mechanical activation via footswitch. Operation: footswitch triggers motor-driven oscillating morcellator blade and simultaneous external suction pump; tissue and distention media evacuated through blade/handpiece into suction tubing. Used in endoscopic procedures by clinicians. Output: mechanical cutting and suction-assisted removal of prostate tissue. Benefits: facilitates efficient tissue removal during endoscopic prostatectomy.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including biocompatibility (ISO 10993 series), reprocessing/sterilization validation (AAMI/ISO standards), and comparative cutting performance testing against the reference device.

Technological Characteristics

Motorized morcellation system; oscillating blade mechanism; AC-powered control unit; wired/wireless footswitch control; 4mm blade diameter; 500-5000 rpm speed range. Biocompatibility per ISO 10993; sterilization per ISO 11137; reprocessing per AAMI TIR12/30/39 and ISO 17664. Software-controlled motor operation.

Indications for Use

Indicated for cutting and removal of enucleated prostate tissue from the lower urinary tract in endoscopic interventions.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Cyber Blade (K192499)

Reference Devices

• Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 (K041610)

Submission Summary (Full Text)

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September 1, 2026

Karl Storz SE & CO. KG
Alita Mcelroy
Regulatory Affairs Manager
Dr.-Karl-Storz-Straße 34
Baden-Wurttemberg
Tuttlingen, 78532
GERMANY

Re: K260884
Trade/Device Name: UNIDRIVE Select System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: GCJ
Dated: March 17, 2026
Received: March 17, 2026

Dear Alita Mcelroy:

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

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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), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 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-

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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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| 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. | K260884 | ? |
| Please provide the device trade name(s). | | ? |
| UNIDRIVE Select System | | |
| Please provide your Indications for Use below. | | ? |
| The UNIDRIVE Select System is intended for cutting and removal of enucleated prostrate tissue from the lower urinary tract in endoscopic interventions. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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K260884

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STORZ
KARL STORZ—ENDOSKOPE

KARL STORZ Premarket Notification

UNIDRIVE Select System

K260884 510(k) Summary

## 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. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Submitter: | KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| --- | --- |
| Contact: | Alita McElroy Regulatory Affairs Manager Phone: [phone] Email : [e-mail] |
| Date of Preparation: | August 26, 2026 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: UNIDRIVE Select System Common Name: Laparoscope, General and Plastic Surgery Classification Name: Laparoscope, General and Plastic Surgery Regulation Name: Endoscope and Accessories Regulation Number: 21 CFR 876.1500 |
| Regulatory Class | II |
| Product Code: | GCJ |
| Classification Panel: | Gastroenterology/Urology |
| Predicate Device(s): | Predicate Device : Cyber Blade (K192499) Reference Device: Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 (K041610) *The predicate has not been subject to a design related recall* |
| Device Description: | The UNIDRIVE Select System is a motorized surgical system that is operated with the software license (UM604) specifically designed for the Urology application and includes the following system components - UNIDRIVE Select motor control unit (UM600) - One-pedal wired footswitch (UF102) - One-pedal wireless footswitch (UF102W) - DrillCut-X II Morcellator Handpiece Uro (27702050) - Handle for DrillCut-X II Morcellator Handpiece URO (40712090) |

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STORZ
KARL STORZ—ENDOSKOPE

K260884
Page 2 of 5

KARL STORZ Premarket Notification

UNIDRIVE Select System

K260884 510(k) Summary

| | - Morcellator Blade (27056LM) - Morcellator Blade (091244-01/-10) - Morcellator Blade (091234-01/-10)The UNIDRIVE Select motor control unit is used with the DrillCut-X II Morcellator Handpiece Uro which houses either reusable or single use morcellator blades. To enable cutting, the morcellator blade is activated either by the wired or wireless one-pedal footswitch that is connected to the UNIDRIVE Select motor control unit. The footswitch simultaneously activates the movement of the morcellator blade and the suction. The morcellated tissue and distention media are evacuated through the morcellator blade and handpiece via the suction tubing. | | | |
| --- | --- | --- | --- | --- |
| Indications for Use: | The UNIDRIVE Select System is intended for cutting and removal of enucleated prostrate tissue from the lower urinary tract in endoscopic interventions. | | | |
| Technological Characteristics. | | **UNIDRIVE Select System Subject Device** | **Cyber Blade Predicate Device (K192499)** | **Comparison to Predicate** |
| | **System Components** | UNIDRIVE Select Control Unit Wired Footswitch Wireless Footswitch DrillCut-X II Morcellator Handpiece Uro Handle for Morcellator Handpiece Morcellator Blades | Handpiece with integrated motor Morcellator Blade AC powered Battery Charger Suction Tube Suction Canister | Standalone motor control unit versus integrated motor in handpiece. Wired and wireless footswitch versus hand controlled |
| | **Principle of Operation** | Morcellation through the cutting effect of the cutting window, produced by | Morcellation through the cutting effect of the cutting window, produced by the relative movement of the internal tube and the | same |

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STORZ
KARL STORZ—ENDOSKOPE

K260884
Page 3 of 5

KARL STORZ Premarket Notification

UNIDRIVE Select System

K260884 510(k) Summary

| | | the relative movement of the internal tube and the external tube of the blades powered by the motor | external tube of the blades powered by the motor | |
| --- | --- | --- | --- | --- |
| | Power Supply | Morcellator is AC power supplied Wireless Footswitch is Battery powered (AC powered charger for battery) | Morcellator is Battery Powered (AC powered charger for battery) | AC powered versus battery powered |
| | Morcellator Blade types | Oscillating | Oscillating | same |
| | Morcellator Blade Diameter | 4mm | 4.5mm | In the same range |
| | Rotational Speed | Minimum-500rpm Default-2000rpm Maximum-5000rpm | Not disclosed | Speed range between 500rpm – 5000rpm |
| | Suction | Continuous suction via External pump | Continuous suction via External pump | same |
| The technological differences between the subject and predicate device do not raise different questions of safety and effectiveness. | | | | |
| Non-Clinical | There are no performance standards or special controls developed under Section 514 of the FD&C Act for the UNIDRIVE Select System. However, | | | |

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K260884
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**STORZ**
KARL STORZ—ENDOSKOPE

*KARL STORZ Premarket Notification
UNIDRIVE Select System
K260884 510(k) Summary*

| Performance Data: | the UNIDRIVE Select System follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance: **Biocompatibility Summary** - Cytotoxicity (ISO 10993-5) - Sensitization (ISO 10993-10) - Irritation (ISO 10993-23) - Acute Systemic Toxicity (ISO 10993-11) - Material Mediated Pyrogenicity (Rabbit Pyrogen Study per USP) **Reprocessing and Sterilization** - AAMI TIR12: 2020 - AAMI TIR30: 2011 - AAMI TIR39: 2009 - ANSI/AAMI ST79:2017 - ANSI/AAMI/ISO 17655-1:2006/2013 - ANSI/AAMI/ISO 17655-2:2009 - ISO17664-1:2021 - ISO 17664-2:2021 - Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling - ISO 11137-1:2025 - ISO 11137-2:2013 - ISO 11137-3:2017 The cutting performance of the subject device, UNIDRIVE Select System has been successfully demonstrated by comparing to the reference device Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 (K041610). Software and Cybersecurity The system complies with the following guidance: - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Cybersecurity in Medical Devices: Quality Management System Considerations and Contents of Premarket Submissions |
| --- | --- |
| Clinical Performance Data: | Clinical Testing was not required to demonstrate substantial equivalence to the predicate device. Non-clinical testing was adequate to establish substantial equivalence. |

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STORZ
KARL STORZ—ENDOSKOPE

K260884

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KARL STORZ Premarket Notification

UNIDRIVE Select System

K260884 510(k) Summary

| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe and effective as the predicate device to support a substantial equivalence determination. |
| --- | --- |

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