← Product Code [FMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF) · K964597 # BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE (K964597) _Biosurgical Corp. · FMF · Sep 8, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K964597 ## Device Facts - **Applicant:** Biosurgical Corp. - **Product Code:** [FMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF.md) - **Decision Date:** Sep 8, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5860 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The BioSurgical Corp. Multi Chamber Suction Syringe is indicated for the mixing and application of FDA approved fluids to wounds, the delivery of antibiotics, and other wound treatment fluids. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound. ## Device Story Multi-chamber suction syringe designed for wound management; enables mixing and delivery of therapeutic fluids (e.g., antibiotics) to wound sites; features attachment capability for standard hospital wall suction to facilitate debridement and removal of fluid debris, excess tissue, or foreign particles. Used by clinicians in hospital settings to streamline wound irrigation and suction procedures. Device provides a dual-function tool for fluid application and wound cleaning, potentially improving efficiency in wound care workflows. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Multi-chamber syringe assembly; manual operation; compatible with standard hospital wall suction systems; non-powered; materials and sterilization methods not specified. ## Regulatory Identification A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. ## 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 Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Jeffrey M. Cohen Founder Biosurgical Corporation 592 Rosso Court Pleasanton, California 94566 SEP - 8 1997 Re: K964597 Trade Name: Biosurgical, Corporation Multi Chamber Suction Syringe Regulatory Class: II Product Code: FMF Dated: June 23, 1997 Received: June 24, 1997 Dear Mr. Cohen: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1} Page 2 - Mr. Cohen through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, ![img-0.jpeg](img-0.jpeg) Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} BioSurgical CORPORATION BioSurgical Corporation 592 Rosso Court Pleasanton, California 94566 K964597 Phone: 510-484-4230 Fax: 510-484-3037 November 15, 1996 Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, MD 20850 **Indications for Use Statement** BioSurgical Corp. Multi Chamber Suction Syringe The BioSurgical Corp. *Multi Chamber Suction Syringe* is indicated for the mixing and application of FDA approved fluids to wounds, the delivery of antibiotics, and other wound treatment fluids. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound. Jeffrey M. Cohen Founder Gordon H. Epstein, MD Founder Prescription fee ☑ (per 21 CFR 801.109) --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K964597](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K964597) **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