Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)

K252926 · Restore Robotics · QSM · Mar 26, 2026 · Gastroenterology, Urology

Device Facts

• Record ID: K252926
• Device Name: Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
• Applicant: Restore Robotics
• Product Code: QSM · Gastroenterology, Urology
• Decision Date: Mar 26, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery. The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Device Story

Remanufactured robotic surgical instruments (cautery hook and spatula); used with da Vinci X/Xi Surgical Systems. Input: manual control signals from surgeon via robotic console; Output: mechanical tissue manipulation and monopolar electrocautery. Components: housing, shaft, wrist, tip. Operation: instruments provide enhanced dexterity/range of motion for minimally invasive surgery; used by trained physicians in OR. Remanufacturing process restores used instruments to OEM specifications for up to 10 additional clinical cycles via validated inspection, repair, cleaning, and testing. Benefit: extends instrument life while maintaining original performance, safety, and clinical utility.

Clinical Evidence

Bench testing only. Evaluations included biocompatibility (ISO 10993), functional mechanical/electrical performance, cleaning validation (protein, hemoglobin, TOC residue analysis), and electrical safety (IEC 60601-1). No clinical data presented.

Technological Characteristics

Reusable, non-sterile robotic instruments. Components: housing, shaft, wrist, tip. Energy: monopolar electrocautery. Connectivity: mechanical interface with da Vinci X/Xi systems. Standards: ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety).

Indications for Use

Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy, requiring tissue dissection and division via monopolar cautery.

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

• da Vinci X Surgical System (K131861)
• da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments (K203632)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 26, 2026

Restore Robotics

Kevin May

Chief Operating Officer

15 Longevity Dr.

Building C

Henderson, Nevada 89014

Re: K252926

Trade/Device Name: Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)

Regulation Number: 21 CFR 876.1500

Regulation Name: Endoscope And Accessories

Regulatory Class: Class II

Product Code: QSM

Dated: February 13, 2026

Received: February 13, 2026

Dear Kevin May:

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.

U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

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K252926 - Kevin May
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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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K252926 - Kevin May
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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 TRUMBORE -S
Digitally signed by
MARK TRUMBORE -S
Date: 2026.03.26
14:40:15 -04'00"

Mark Trumbore Ph.D.
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Page 9 of 45

| 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. | K252926 |
| Please provide the device trade name(s). | |
| Robotic Surgical Instruments - Permanent Cautery Hook (470183);
Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | |
| Please provide your Indications for Use below. | |
| The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula
(470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System –
Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be
used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with
monopolar cautery.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is
intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid
endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders,
endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including
grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery
and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical
procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures,
general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The
system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during
cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by
trained physicians in an operating room environment in accordance with the representative, specific
procedures set forth in the Professional Instructions for Use. | |
| 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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| 510(k) #: K252926 | 510(k) Summary | Prepared on: 2026-02-13 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Restore Robotics | |
| Applicant Address | 15 Longevity Dr. Building C Henderson NV 89014 United States | |
| Applicant Contact Telephone | 678.619.0011 | |
| Applicant Contact | Mr. Kevin May | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | |
| Common Name | Robotic Surgical Instruments | |
| Classification Name | Robotic Surgical Instruments | |
| Regulation Number | 21 CFR §876.1500 | |
| Product Code(s) | QSM, NAY | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K131861 | da Vinci X Surgical System | NAY |
| K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments | NAY |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery. Each instrument consists of four primary components: the housing, shaft, wrist, and tip. The shaft and wrist enable multiple axes of articulation, while the tip is designed for direct interaction with tissue. When operated in conjunction with the appropriate robotic system, these instruments provide enhanced dexterity and a greater range of motion than the human hand, facilitating precise tissue manipulation and dissection in minimally invasive procedures. The remanufactured devices are intended for up to ten (10) additional clinical use cycles beyond the OEM-cleared use life, as supported by validated reprocessing and performance testing. The design, materials, and intended use are identical to the Predicate Device (K131861) in form, fit, and function. The mechanism of action is unchanged and remains based on the same fundamental mechanical architecture and dimensions. There are no changes to: - The indications for use | | |

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- Clinical applications
- Patient population
- Performance specifications
- Method of operation

In accordance with the Design Control process, a comprehensive risk analysis was conducted to evaluate the impact of remanufacturing. The remanufacturing process includes validated inspection, repair, testing, and cleaning procedures to ensure safety and effectiveness. Design verification and validation activities confirmed that the Subject Devices meet all applicable design input requirements. The following evaluations were performed, or rationales were provided where testing was not required, consistent with applicable standards and FDA guidance:

- Biocompatibility (per ISO 10993)
- Functional performance testing (mechanical and electrical)
- Cleaning validation (including protein, hemoglobin, and TOC residue analysis)
- Electrical safety testing (per IEC 60601-1 and relevant clauses)

Test results support that the remanufactured instruments are as safe and effective as the Predicate Devices and meet all required specifications for intended use.

Additionally, FDA-cleared Reference Device (K203632) is cited to support the validated cleaning and reprocessing methods associated with the proposed ten (10) reuse cycles.

## Intended Use/Indications for Use

21 CFR 807.92(a)(5)

The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

## Indications for Use Comparison

21 CFR 807.92(a)(5)

The Subject Devices, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), have the same intended use as the Predicate Device (da Vinci X Surgical System, (K131861). Both are intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. These devices are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery.

Although the indications for use statements differ in scope, this reflects only the level of description. The Predicate Device describes the surgical system, while the Subject Devices describe the compatible instruments. These differences do not alter the underlying intended use or raise new questions of safety or effectiveness.

The Subject Devices do not introduce any new clinical applications, anatomical targets, user populations, or surgical modalities. Therefore, consistent with 21 CFR 807.92 and FDA's The S10(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (2014) guidance, these differences in indication wording do not constitute a new or different intended use.

## Technological Comparison

21 CFR 807.92(a)(6)

The Subject Devices, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are identical in design, materials, dimensions, and functional characteristics to the instruments cleared for use with the da Vinci X Surgical System (K131861). Both the

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Predicate and Subject Devices enable endoscopic tissue dissection using monopolar electrocautery.

The remanufacturing process does not introduce any new technological characteristics. It restores previously used instruments to their original form, fit, and function through validated inspection, cleaning, repair, and testing procedures. All mechanical, electrical, and performance attributes remain consistent with those of the Predicate Device.

Accordingly, the Subject Devices have the same intended use and technological characteristics as the Predicate Device, and no new questions of safety or effectiveness are raised. The remanufactured Subject Devices perform equivalently to the Predicate Device cleared under K131861, as demonstrated through design verification, cleaning validation, and functional testing.

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

In accordance with the Design Control process, a comprehensive risk analysis was conducted to evaluate the impact of remanufacturing. The remanufacturing process includes validated inspection, repair, testing, and cleaning procedures to ensure safety and effectiveness. Design verification and validation activities confirmed that the Subject Devices meet all applicable design input requirements.

The following evaluations were performed, or rationales were provided where testing was not required, consistent with applicable standards and FDA guidance:

- Biocompatibility (per ISO 10993)
- Functional performance testing (mechanical and electrical)
- Cleaning validation (including protein, hemoglobin, and TOC residue analysis)
- Electrical safety testing (per IEC 60601-1 and relevant clauses)

Test results support that the remanufactured instruments are as safe and effective as the Predicate Device(s) and meet all required specifications for intended use.

Additionally, FDA-cleared Reference Device (K203632) is cited to support the validated cleaning and reprocessing methods associated with the proposed ten (10) reuse cycles.