ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)

K244029 · Endorobotics Co., Ltd. · FDF · Sep 24, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K244029
• Device Name: ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
• Applicant: Endorobotics Co., Ltd.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Sep 24, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ROBOPERA is intended to hold and lift the tissue and mucosal membrane within the esophagus, stomach, colon, and rectum of the gastrointestinal tract, excluding the small intestine, during endoscopic surgical procedures. It is intended to be used by trained physicians in a hospital.

Device Story

ROBOPERA is an electromechanical, software-controlled endoscopic accessory system consisting of a driving unit, instrument (Articulated Basic or Dual Gripper), and controller. The system mounts to an endoscope; the driving unit motor transmits physical force via cables to the forceps instrument. The physician operates the controller to perform grip, wrist, arm, and roll movements. The device is used in hospitals to grasp, lift, and fix mucosal membranes during endoscopic mucosal incision or resection (ESD) and assists in clipping. By providing precise, controllable tissue manipulation, the device aids in submucosal dissection, potentially improving procedural efficiency and accuracy compared to manual grasping tools.

Clinical Evidence

No clinical studies were performed. Evidence consists of bench testing (dimensional, motion, tensile strength, reliability, corrosion, endoscope compatibility), usability testing (formative and summative), and an animal validation study. The animal study evaluated the device's ability to precisely and controllably dissect the submucosal layer during ESD in simulated clinical scenarios, demonstrating performance substantially equivalent to the predicate.

Technological Characteristics

Electromechanically operated, software-controlled endoscopic accessory. Materials: Stainless steel. Sterilization: Ethylene Oxide (ISO 11135). Connectivity: Standalone system with controller and driving unit. Safety standards: IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-1-6:2010/AMD2:2020. Biocompatibility: ISO 10993-1. Articulation: Variable range.

Indications for Use

Indicated for trained physicians in a hospital setting to hold and lift tissue and mucosal membrane in the esophagus, stomach, colon, and rectum (excluding small intestine) during endoscopic surgical procedures.

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

• HX Device (K173919)

Reference Devices

• Grasping Forceps (K152802)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

September 24, 2025

EndoRobotics Co., Ltd.
% Jonghyun Kim
Official Correspondent
Global Medical Standard Consulting Co., Ltd.
66, Cheongcho-ro,
Deogyang-gu, Goyang-si
Gyeonggi-do, 10543
Korea, South

Re: K244029
Trade/Device Name: ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FDF, FDS, NAY
Dated: December 30, 2024
Received: August 25, 2025

Dear Jonghyun Kim:

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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K244029 - Jonghyun Kim
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 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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K244029 - Jonghyun Kim
Page 3

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,

# Shanil P. Haugen -S

Shanil P. Haugen, Ph.D.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant 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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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) K244029 | |
| Device Name ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | |
| Indications for Use (Describe) The ROBOPERA is intended to hold and lift the tissue and mucosal membrane within the esophagus, stomach, colon, and rectum of the gastrointestinal tract, excluding the small intestine, during endoscopic surgical procedures. It is intended to be used by trained physicians in a hospital. | |
| 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 [e-mail] | |
| "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." | |

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K244029 Page 1 of 8

# 510(K) Summary
K244029

C

ENDOROBOTICS

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# 510(k) Summary - K244029

[As Required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

December 30, 2024

2. Submitter's Information [21 CFR 807.92(a)(1)]

- Name of Manufacturer: EndoRobotics Co., Ltd.
- Address: 14-15 floor, 57, Deahk-ro, Jongno-gu Seoul Korea, South (Zip: 03082)
- Contact Name: Jihwan Kim / Regulatory Affairs Manager
- Telephone No.: [phone]
- Email Address: [e-mail]

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

- Trade Name: ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)

| Common Name | Colonoscope and Accessories |
| --- | --- |
| Regulation Name | Endoscope and accessories |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | FDF, FDS, NAY |
| Device Class | II |

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## 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

### Predicate Device

- 510(k) Number: K173919
- Applicant: Human Extension Ltd.
- Classification Name: Endoscope and accessories
- Trade Name: HX Device
- Product Code: GCJ, NAY

### Reference Device

- 510(k) Number: K152802
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Classification Name: Endoscope and accessories
- Trade Name: Grasping Forceps
- Product Code: OCZ

## 5. Description of the Device [21 CFR 807.92(a)(4)]

This product consists of a driving unit, an instrument, and a controller. The forceps of the instrument are mounted on the outer tip of the endoscope, the cartridge is inserted into the driving unit, and the controller is mounted on the endoscope boot.

The user can perform four operations (Grip, Wrist, Arm, Roll) of the instrument (Articulated Basic Gripper G), and three operations (Grip A, B, Arm, Roll) of the instrument (Articulated Dual Gripper G) through the controller.

In this product, the power generated through the motor in the driving unit is transmitted to the forceps in a physical way through the instrument cartridge and cable, and the forceps can perform four movements: grip, wrist, arm, and roll using the transmitted force to catch and lift and fix the mucous membrane of the lesion during mucosal incision or resection using an endoscope. In addition, after mucosal incision and resection, it can play a role of assisting in clipping by catching and collecting a part of the mucous membrane.

### ROBOPERA Configurations:

| Model Name | Description |
| --- | --- |
| ER-R-002 | Driver Unit + Instrument (Articulated Basic Gripper G) |
| ER-R-003 | Driver Unit + Instrument (Articulated Dual Gripper G) |

## 6. Indications for use [21 CFR 807.92(a)(5)]

The ROBOPERA is intended to hold and lift the tissue and mucosal membrane within the esophagus, stomach, colon, and rectum of the gastrointestinal tract, excluding the small intestine, during endoscopic surgical procedures. It is intended to be used by trained physicians in a hospital.

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# 7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(4)]

The table below presents comparisons between the subject device (ROBOPERA) and the legally marketed predicate devices (K173919):

[Table 1. Comparison of Subject Device to Predicate Device]

| | Subject Device | Predicate Device | Reference Device | Remark |
| --- | --- | --- | --- | --- |
| Product Name | ROBOPERA | HX Device | Grasping Forceps | - |
| Product Code | FDF, FDS, NAY | GCJ, NAY | OCZ | - |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Regulatory Class | Class II | Class II | Class II | Same |
| Indications for Use | The ROBOPERA is intended to hold and lift the tissue and mucosal membrane within the esophagus, stomach, colon, and rectum of the gastrointestinal tract, excluding the small intestine, during endoscopic surgical procedures. It is intended to be used by trained physicians in a hospital. | The HX Device is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use. | Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract. | Same |
| Prescription Use | Prescription Use only | Prescription Use only | Prescription Use only | Same |
| Operational Environments | Hospital | Hospital | Hospital | Same |
| Mode of Operation | Electromechanically operated, software controlled | Electromechanically operated, software controlled | Manually operated | Same |

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| Component | Driver unit, Controller (A, B), Instrument (A, B), Power cable, Controller Holder. ENJECT Tool, Sleeve Tube | Handpiece and compatible instruments (Grasper, Needle Holder); Arc, Pads, Spacer, Power Cable | Jaws, spring sheath, finger ring | Similar |
| --- | --- | --- | --- | --- |
| Articulation range | Variable | Variable | None | Similar |
| Material | Stainless steel | Stainless steel | Stainless steel | Same |
| Single Use/Reusable | Single Use | Single Use for Instrument | Single Use | Same |
| Sterilization method | Ethylene Oxide Gas Sterilization | Ethylene Oxide Gas Sterilization | Ethylene Oxide Gas Sterilization | Same |
| Safety | IEC 60601-1:2005+A1:2012 | IEC 60601-1:2005+A1:2012 | None | Same |
| EMC | IEC 60601-1-2:2014 4th E | IEC 60601-1-2:2014 4th E | None | Same |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same |

The indications for use of the subject, predicate and reference device are similar, and they have the same intended use.

The subject, predicate and reference devices have similar technological features. However, as shown in the table above, there are technological differences between the subject, predicate and reference devices. The different technological characteristics of the subject device, as compared to the predicate and reference devices, do not raise different questions of safety and effectiveness.

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# 8. PERFORMANCE DATA [21 CFR 807.92(b)(1)]

## 1) EMC, Wireless, and Electrical, Mechanical and Thermal Safety

The test results demonstrated that the proposed device complies with the following standards:

- Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AMD2:2020
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014+A1:2020
- Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability in accordance with IEC 60601-1- 6:2010/AMD2:2020

## 2) Reprocessing, Sterility and Shelf-Life

- Sterilization and shelf life testing

The sterilization method has been validated to ISO 11135:2014, which has thereby determined the routine control and monitoring parameters.

EO/ECH residual test was performed according to ISO 10993-7:2008.

The shelf life (2 years) of the Single-Use Digital Flexible Ureteroscope is determined based on stability study which includes ageing test according to ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier.

## 3) Software

The software was designed and developed according to IEC 62304 software development process and was verified and validated. According to the guidance, we evaluated the level of Basic level documentation by identifying safety-related characteristics for device documentation level.

- The software information is provided in accordance with FDA guidance: Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff', issued on JUNE 2023.

## 4) Performance Testing

Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:

| - Dimensional Attributes Verification | - Forceps Instrument Reliability Evaluation |
| --- | --- |
| - Device Motion Performance | - Instrument Corrosion |
| - Emergency Stop button | - Endoscope compatibility |
| - Forceps instrument articulation control test | - Forceps instrument motion performance test |
| - Controller performance test | - Eject tool performance test |
| - Tensile strength of connection between device components | |

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## 5) Human factor

Usability testing was conducted. Formative Test and Summative Test were conducted in accordance with IEC 62366-1:2015+AMD1:2020 CSV

(Medical devices – Part 1: Application of usability engineering to medical devices)

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## 6) Animal Testing

This study was conducted in accordance with a study protocol written following FDA Guidelines. It aimed to evaluate the ability of the forceps to precisely and controllably dissect the submucosal layer during ESD based on real clinical scenarios.

The results of the animal validation tests showed that the preclinical animal study of the electrically powered endoscopic therapeutic forceps (ROBOPERA) was designed to assess the safety and efficacy of the device in the specific context of ESD. The study protocol focused on simulating real clinical scenarios to evaluate the forceps' ability to precisely and controllably dissect the submucosal layer and demonstrated substantially equivalent accuracy to the predicate device.

- The animal study information is provided in accordance with FDA guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued on March 28, 2023

## 7) Biocompatibility

Biocompatibility studies, including irritation, cytotoxicity, and sensitization testing were performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process", as follows:

| - Cytotoxicity | ISO 10993-5:2009 |
| --- | --- |
| - Sensitization | ISO 10993-10:2021 |
| - irritation: | ISO 10993-23:2021 |
| - Acute systemic toxicity | ISO 10993-11:2017 |
| - material mediated
pyrogenicity | ISO 10993-11:2017 |

The user-contacting materials were shown to be non-cytotoxic, non-irritating, non-sensitizing and non-acute.

## 8) Clinical Test Summary:

The subject of this premarket submission did not require clinical studies were considered necessary and performed.

## 9. Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification EndoRobotics Co., Ltd. concludes that the ROBOPERA is substantially equivalent in safety and effectiveness to the predicate devices as described herein.