← Product Code [KGE](/submissions/GU/subpart-e%E2%80%94surgical-devices/KGE) · K090583 # ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 (K090583) _Apollo Endosurgery, Inc. · KGE · Jun 26, 2009 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KGE/K090583 ## Device Facts - **Applicant:** Apollo Endosurgery, Inc. - **Product Code:** [KGE](/submissions/GU/subpart-e%E2%80%94surgical-devices/KGE.md) - **Decision Date:** Jun 26, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4300 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The Apollo Endosurgery Endoscopic Monopolar Scissors are designed to cut, dissect, and cauterize tissue during flexible endoscopic procedures. ## Device Story Device consists of flexible metal shaft with distal scissors and proximal handle; handle includes connection for monopolar electrocautery source. Used in flexible endoscopic procedures by physicians. Operates via mechanical cutting (scissors blades) and electrosurgical cutting (monopolar cautery). Device provides mechanical and electrosurgical tissue management capabilities to assist in endoscopic interventions. ## Clinical Evidence Bench testing only. Testing included dimensional, visual, atraumatic tip, tortuous path, handle pull strength, resistivity, electrocautery, and scissors performance. All tests met acceptance criteria. ## Technological Characteristics Flexible metal shaft; distal scissors; proximal handle with monopolar electrocautery connection. Materials are biocompatible and previously cleared. No software or electronic processing components. ## 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. ## Predicate Devices - TeleMed Systems Flexible Endoscopic Scissors ([K011412](/device/K011412.md)) - Logic Laparoscopic Monopolar Scissors ([K063485](/device/K063485.md)) ## 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}------------------------------------------------ K090583 pg, of JUN 26 2009 ### 510(k) Summary General Information Classification Trade Name Submitter Class II Endoscopic Monopolar Scissors Apollo Endosurgery, Inc. 7000 Bee Cave Road Suite 350 Austin, Texas 78746 Tel: (512) 328-9990 Contact Greg Mathison Vice President Regulatory Indications for Use The Apollo Endosurgery Endoscopic Monopolar Scissors are designed to cut, dissect, and cauterize tissue during flexible endoscopic procedures. Predicate Devices TeleMed Systems Flexible Endoscopic Scissors K011412 TeleMed Systems Inc. K063485 Logic Laparoscopic Monopolar Scissors Surgical Innovations Group #### Device Description The Endoscopic Monopolar Scissors is comprised of a flexible metal shaft with a distal mounted scissors which is operated by a proximal handle. The proximal handle also has connections for a monopolar electrocautery source. The scissor blades function as standard scissors for mechanical cutting and for standard electrosurgical cutting, as required. {1}------------------------------------------------ ### Materials K090583 pg 2 of 2 All materials used in the manufacture of the Endoscopic Monopolar Scissors are suitable for this use and have been used in numerous previously cleared products. ## Testing Product testing was completed and met all of the acceptance criteria. Testing included dimensional, visual, atraumatic tip, tortuous path, handle pull strength, resistivity, electrocautery and scissors performance. ### Summary of Substantial Equivalence The Endoscopic Monopolar Scissors is equivalent to the features of the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol. The symbol is black and white. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 26 2009 Mr. Gegory Mathison Vice President, Regulatory Affairs Apollo Endosurgery 7000 Bee Caves Road. Suite 350 AUSTIN TX 78746 Re: K090583 Trade/Device Name: Endoscopic Monopolar Scissors Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KGE Dated: June 15, 2009 Received: June 17, 2009 Dear Mr. Mathison: 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 {3}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrb/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Jarine M. Morris Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ /K0905.83 # Indications for Use 510(k) Number (if known): Device Name: Indications for Use: K090583 Endoscopic Monopolar Scissors The Apollo Endosurgery Endoscopic Monopolar Scissors are designed to cut, dissect, and cauterize tissue during flexible endoscopic procedures. Prescription Use X (Per 21 CFR 801.109) OR S 21 Over-The-Counter Use (Optional Format 1-2-96) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Samual M. Mass (Division Sign-Øff) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _ Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KGE/K090583](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KGE/K090583) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com