DSNARE, MODEL 00711087

K051637 · United States Endoscopy Group, Inc. · FCK · Oct 31, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051637
• Device Name: DSNARE, MODEL 00711087
• Applicant: United States Endoscopy Group, Inc.
• Product Code: FCK · Gastroenterology, Urology
• Decision Date: Oct 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The dSnare™ disposable Diminutive Polyp Device is a non-diathermic polypectomy snare with a suction retention retrieval feature device indicated for transendoscopic cold polypectomy and suction retrieval of lesions between 3mm and 7mm in size.

Device Story

dSnare™ is a non-diathermic, disposable polypectomy snare designed for use during endoscopic procedures. It features a suction retention retrieval mechanism. The device is operated by a physician to perform cold polypectomy on diminutive lesions (3mm-7mm). By combining snare resection and suction retrieval, the device allows for the removal and capture of polyps in a single step, potentially reducing procedure time and improving lesion recovery compared to traditional separate snare and retrieval tools.

Clinical Evidence

bench testing only

Technological Characteristics

Non-diathermic, disposable endoscopic snare; mechanical suction retention mechanism; manual operation; compatible with standard endoscopes.

Indications for Use

Indicated for transendoscopic cold polypectomy and suction retrieval of lesions 3mm to 7mm in size.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002

US Endoscopy
Ms. Gretchen Y. Cohen
Executive Vice President
5976 Heisley Road
Mentor, OH 44060

JUL 27 2015

Re: K051637
Trade/Device Name: dSnare™ disposable Diminutive Polyp Device
Regulation Number: 21 CFR 876.4300
Regulation Name: Endoscopic electrosurgical unit accessories
Regulatory Class: II
Product Code: FDI, FCK
Dated (Date on orig SE ltr): September 30, 2005
Received (Date on orig SE ltr): October 3, 2005

Dear Ms. Cohen,

This letter corrects our substantially equivalent letter of October 31, 2005.

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 (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. 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

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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*.

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D.
Director
Division of Reproductive, Gastro-Renal, and Urological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K051637

Device Name: dSnare™ disposable Diminutive Polyp Device

Indications for Use:

The dSnare™ disposable Diminutive Polyp Device is a non-diathermic polypectomy snare with a suction retention retrieval feature device indicated for transendoscopic cold polypectomy and suction retrieval of lesions between 3mm and 7mm in size.

Prescription Use ☑ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segnori
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K051637

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