← Product Code [KKX](/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX) · K112378 # COBES SURGICAL DRAPE (K112378) _Cobes Industries Co., Ltd. · KKX · May 8, 2012 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K112378 ## Device Facts - **Applicant:** Cobes Industries Co., Ltd. - **Product Code:** [KKX](/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX.md) - **Decision Date:** May 8, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4370 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use Cobes Sterile Surgical Drape is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination. ## Device Story Cobes Sterile Surgical Drape (Models D2001B and D2001G) functions as a physical protective barrier. Used in clinical settings, it is applied by healthcare professionals to isolate surgical incision sites from microbial and other contaminants. The device is a single-use, sterile product designed to reduce the risk of surgical site contamination during procedures. ## Clinical Evidence Bench testing only. ## Technological Characteristics Single-use sterile surgical drape. Materials and design consistent with standard surgical drape requirements for microbial barrier protection. Class II device (21 CFR 878.4370). ## Regulatory Identification A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. ## Special Controls *Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. ## 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}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES 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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines, possibly representing the flow of health services. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Cobes Industries Company, Ltd C/O Mr. Leon Lu Director of Quality and Regulatory Affairs MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901 - 8 2012 MAY Re: K112378 Trade/Device Name: Cobes Sterile Surgical Drape, Model D2001B and D2001G Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 8, 2012 Received: April 10, 2012 Dear Mr. Lu: 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. {1}------------------------------------------------ #### Page 2 - Mr. Lu 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 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Antony O. Amater Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use # 510(k) Number (if known): K (12378 Device Name: Cobes Sterile Surgical Drape, Model D2001B and D2001G ## Indications for Use: Cobes Sterile Surgical Drape is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination. Over-The-Counter Use _ × AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) Fall 2 PCF N 00 Foubpart D/ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elish H. Clamin-Will (Division Sign-Off) (Division Sign-On) Division of Anesthesiology, General Hospital Division Control, Dental Devices 510(k) Number: _______________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K112378](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K112378) **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