K250993 · Olympus Medical Systems Corporation · FDX · Dec 18, 2025 · Gastroenterology, Urology
Device Facts
Record ID
K250993
Device Name
Single Use Cytology Brush V (BC-V600P-3010)
Applicant
Olympus Medical Systems Corporation
Product Code
FDX · Gastroenterology, Urology
Decision Date
Dec 18, 2025
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The Single Use Cytology Brush V BC-V600P-3010 is intended to be used to collect tissue specimens in the biliary system in combination with an endoscope.
Device Story
Single-use endoscopic cytology brush; used to collect tissue/cell specimens from biliary system. Device inserted through duodenoscope instrument channel to target site. Physician operates handle grip to extend/retract brush from distal tube; brush rubbed against target area to collect samples. Includes injection port for contrast medium, locking cap for brush positioning, and hook for endoscope attachment. Radiopaque marks allow visualization on X-ray monitor. Guidewire inserted into distal tip to assist navigation. Withdrawn from endoscope channel with collected samples for cytologic examination. Benefits patient by enabling minimally invasive tissue sampling for diagnostic evaluation.
Clinical Evidence
Bench testing and animal study conducted. Bench testing verified insertion/withdrawal, brush extension/retraction, locking cap performance, and connection strength. Animal study (living pig bile duct) compared collected sample quantity and quality against predicate device, confirming effectiveness for biliary cytology.
Technological Characteristics
Single-use endoscopic accessory. Materials evaluated per ISO 10993-1. Features include handle with grip, operation pipe, locking cap, injection port, and hook. Insertion portion includes wires, tube, radiopaque markers, brush, and distal tip. Compatible with Ø 4.2mm endoscope channels and Ø 0.89mm (0.035 inch) guidewires. Sterilized via Ethylene Oxide (EO).
Indications for Use
Indicated for collection of tissue specimens in the biliary system in patients undergoing endoscopic 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.
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.
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FDA U.S. FOOD & DRUG ADMINISTRATION
December 18, 2025
Olympus Medical Systems Corporation
Eve Smith
Regulatory Affairs Specialist II
2951 Ishikawa-cho
Hachioji-shi, Tokyo 192-8507
Japan
Re: K250993
Trade/Device Name: Single Use Cytology Brush V (BC-V600P-3010)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FDX
Dated: November 3, 2025
Received: November 3, 2025
Dear Eve Smith:
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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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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K250993 - Eve Smith
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
ANTHONY LEE -S
Anthony Lee, Ph.D., MBA
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 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250993 | |
| Device Name Single Use Cytology Brush V (BC-V600P-3010) | |
| Indications for Use (Describe) The Single Use Cytology Brush V BC-V600P-3010 is intended to be used to collect tissue specimens in the biliary system in combination with an endoscope. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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K250993 page 1 of 5
OLYMPUS
TRADITIONAL 510(K) NOTIFICATION SINGLE USE CYTOLOGY BRUSH V BC-V600P-3010
# 510(k) Summary
For
# Single Use Cytology Brush V BC-V600P-3010
## General Information
Applicant: OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
Phone: (+81) 42-642-2111
Fax: (+81) 42-642-2307
Establishment Registration Number: 8010047
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
510(k) Submitter: Olympus Corporation of the Americas
3500 Corporate Parkway
Center Valley, PA 18034
Contact Person: Eve Smith
Regulatory Specialist II
Mobile: (267) 373-7633
Email: eve.smith@olympus.com
Date Prepared: March 26, 2025
## Device Description
Device Name: Single Use Cytology Brush V BC-V600P-3010
Generic/Common Name: Single Use Cytology Brush
Regulation Number: 21CFR 876.1500
Regulatory Class: Class II
Classification Name: Endoscope and Accessories
Product Codes: FDX
Review Panel: Gastroenterology & Urology
## Predicate Device
| Device Name | 510(k) Submitter | 510(k) No. |
| --- | --- | --- |
| Fusion Cytology Brush | Wilson-Cook Medical, Inc. | K192908 |
510(k) Summary
Page 1 of 5
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K250993 page 2 of 5
OLYMPUS
TRADITIONAL 510(K) NOTIFICATION SINGLE USE CYTOLOGY BRUSH V BC-V600P-3010
## Indications for Use
The Single Use Cytology Brush V BC-V600P-3010 is intended to be used to collect tissue specimens in the biliary system in combination with an endoscope.
## Device Description
BC-V600P-3010 has been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with duodenoscopes. BC-V600P-3010 is inserted into the duodenoscope through an instrument channel to reach the target area, where, by rubbing the brush on the target area, specimens or cells can be collected. BC-V600P-3010 is then withdrawn from the duodenoscope channel with the collected samples.
The handle is connected to operating wires. The grip on the handle portion controls the brush movement inside the tube. By pushing/pulling the handle, the brush at the distal end of the Subject device can be protruded from/drawn into the tube. Cells can be collected by moving over the target site with the brush.
The BC-V600P-3010 consists of:
A. Handle
- Grip: used to push to extend the brush from the tube. Pull to retract the brush back into the tube.
- Operation pipe: used to connect the grip with the wires so that it can transfer the force to push/pull the brush/distal tip.
- Locking cap: used for fixing the location of the brush by turning the locking cap clockwise.
- Injection port: Available to attach a syringe here to inject contract medium.
- Hook: attached to the boot of the endoscope or ET Control Device V (sold separately).
B. Insertion portion
- Wires: connect operation pipe with brush and distal tip to push/pull the brush from/into the tube
- Tube: works as the channel that the contrast media is injected through during use
- V marking: gives the user an approximate indication of how far the instrument has been inserted into the endoscope,
- Radiopaque marks: allow the distal end of the tube to be visualized on the X-ray monitor
- Brush: used to brush the target area to collect samples.
- Distal tip: When using a guidewire, the guidewire is inserted into the distal tip.
510(k) Summary Page 2 of 5
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OLYMPUS
TRADITIONAL 510(K) NOTIFICATION SINGLE USE CYTOLOGY BRUSH V BC-V600P-3010
# Comparison of Technological Characteristics
Table 1 provides a comparison of the intended use, device characteristics and technological features between the subject device and predicate device.
Table 1. Subject and Predicate Device Comparison Table
| Feature / Characteristic | Subject Device (SD) | Predicate Device (PD) |
| --- | --- | --- |
| | Single Use Cytology Brush V BC-V600P-3010 | Fusion Cytology Brush (K192908) |
| Indications for Use | The Single Use Cytology Brush V BC-V600P-3010 is intended to be used to collect tissue specimens in the biliary system in combination with an endoscope. | This device is used for collection of cells in the biliary system. |
| Regulation Number | 876.1500 | 876.1500 |
| Regulation Name | Endoscope and Accessories | Endoscope and Accessories |
| Regulatory Class | Class II | Class II |
| Product Code | FDX (Endoscopic Cytology Brush) | FDX (Endoscopic Cytology Brush) |
| Classification Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| Basic principle | The SD is inserted into the duodenoscope through an instrument channel to reach the target area, where, by rubbing the brush on the target area, specimens or cells can be collected. The SD is then withdrawn from the duodenoscope channel with the collected samples. | The Fusion Cytology Brush is used by passing the device through an endoscope over a prepositioned wire guide to a target location.The cytology brush is located at the distal end (patient contacting) of the device with the pin vise handle located at the proximal end (non-patient contacting). The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush. |
| Shape of the Brush | | |
| Minimum Accessory Channel (mm) | Ø 4.2 | Ø 4.2 |
| Working Length (mm) | 1900 | 2000 |
| Brush Diameter (mm) | Ø 3 | Ø 3 |
| Brush Length (mm) | 10 | 25 |
| Compatible guidewire (mm (inch)) | Ø 0.89 (0.035) | Ø 0.89 (0.035) |
| Reprocessing | Single Use | Single Use |
510(k) Summary
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OLYMPUS
TRADITIONAL 510(K) NOTIFICATION SINGLE USE CYTOLOGY BRUSH V BC-V600P-3010
| Feature / Characteristic | Subject Device (SD) | Predicate Device (PD) |
| --- | --- | --- |
| | Single Use Cytology Brush V BC-V600P-3010 | Fusion Cytology Brush (K192908) |
| Sterilization Method | EO | EO |
The Single Use Cytology Brush V BC-V600P-3010 is substantially equivalent to the legally marketed predicate device based on the claim of substantial equivalence on similarities in technological features with the predicate device:
- same intended use,
- device characteristics (design, materials, and operations) are similar or identical to the predicate device, and
- does not introduce any new or novel treatments or standard of care that differs from predicate device in commercial use.
The guidewire is inserted into the distal tip of the Subject Device, as opposed to the handle section of the Predicate Device. As a result, the tip shape design of the Subject Device has been changed to accommodate the insertion of the guidewire. There is no difference in the purpose and the directions for use of a guidewire, other than the method of insertion.
The brush length and number of bristles is different between the SD and the PD to meet design requirements for insertion/withdrawal forces of the SD into/from compatible endoscopes. This does not change the purpose or direction of the device.
The subject device has an added hook, locking cap and injection port that are not found on the subject device. These features were added for customer ease of use and do not change the purpose or direction of the device.
## Summary of Performance Testing
The following performance testing was conducted in support of substantial equivalence determination.
## Biocompatibility Testing
Biocompatibility testing was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- Cytotoxicity Study using the ISO Elution method (ISO 10993-5)
- Intracutaneous Irritation Study (ISO 10993-23)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10)
- Material-mediated Pyrogen Testing (USP, <151>)
- Acute Systemic Toxicity Study in Mice (ISO 10993-11)
510(k) Summary Page 4 of 5
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OLYMPUS
K250993 page 5 of 5
TRADITIONAL 510(K) NOTIFICATION SINGLE USE CYTOLOGY BRUSH V BC-V600P-3010
- Performance Testing – Bench (Non-Clinical)
Bench tests as listed below were conducted to ensure that the subject device performs as intended and meets design specifications.
- Insertion and Withdrawal of the Subject Device to and from the Endoscope
- Performance after Repeated Insertion and Withdrawal
- Attachment and Detachment of Hook
- Performance after Repeated Attachment and Detachment of Hook
- Performance of Contrast Medium Infusion
- Brush Extension and Retraction from Tube
- Performance after Repeated Brush Extension and Retraction
- Locking Cap Performance
- Brush Strength
- Connection Strength
- Animal Testing
Olympus conducted animal testing to verify that the Subject Device’s dimensions are effective to perform as a cytology brush used to collect cells in the biliary system.
In the animal test, the brush was inserted into a living pig's bile duct, scraped, and the collected samples were compared with the Predicate Device's samples to determine sufficient quantity and quality for cytology.
## Conclusion
In summary, the Single Use Cytology Brush V BC-V600P-3010 is substantially equivalent to the predicate device.
510(k) Summary
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