BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE

K964597 · Biosurgical Corp. · FMF · Sep 8, 1997 · General Hospital

Device Facts

• Record ID: K964597
• Device Name: BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
• Applicant: Biosurgical Corp.
• Product Code: FMF · General Hospital
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Indications for Use

Indicated for mixing and applying FDA-approved wound treatment fluids, including antibiotics, and for suctioning fluid debris, excess tissue, or foreign particles from wounds in clinical settings.

Regulatory Classification

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)

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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BioSurgical CORPORATION
BioSurgical Corporation
592 Rosso Court
Pleasanton, California 94566
K964597
Phone: [phone]
Fax: [phone]

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)