← Product Code [KGE](/submissions/GU/subpart-e%E2%80%94surgical-devices/KGE) · K141794 # ENDO-MARYLAND DISSECTOR (K141794) _Ovesco Endoscopy AG · KGE · Nov 19, 2014 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KGE/K141794 ## Device Facts - **Applicant:** Ovesco Endoscopy AG - **Product Code:** [KGE](/submissions/GU/subpart-e%E2%80%94surgical-devices/KGE.md) - **Decision Date:** Nov 19, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4300 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use Instrument for flexible endoscopy for dissection by blunt spreading of tissue and hemostasis in the gastrointestinal tract ## Device Story Endo-Maryland Dissector is a surgical instrument designed for use in flexible endoscopy. It functions by enabling blunt spreading of tissue for dissection and providing hemostasis within the gastrointestinal tract. The device is operated by a physician during endoscopic procedures. It serves as a mechanical tool to assist in surgical manipulation and bleeding control during gastrointestinal interventions, potentially benefiting patients by facilitating minimally invasive tissue management. ## Clinical Evidence No clinical data provided; device is a mechanical surgical instrument. ## Technological Characteristics Mechanical endoscopic instrument for tissue dissection and hemostasis. Operates via manual manipulation during flexible endoscopy. No electronic, software, or energy-based components described. ## Regulatory Identification An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of a human figure, represented by three overlapping profiles facing to the right, with flowing lines suggesting movement or connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 19, 2014 Ovesco Endoscopy AG Marc O. Schurr Research and Development Dorfackerst. 26 D-72074 Tuebingen Germany Re: K141794 > Trade/Device Name: Endo-Maryland Dissector Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KGE Dated: October 2, 2014 Received: October 8, 2014 Dear Marc O. Schurr, 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 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 {1}------------------------------------------------ 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Herbert P. Lerner -S for Benjamin Fisher Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K141794 # Device Name Endo-Maryland Dissector Indications for Use (Describe) Instrument for flexible endoscopy for dissection by blunt spreading of tissue and hemostasis in the gastrointestinal tract Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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. 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