SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S

K991215 · Symtex Healthcare Corp. · EFQ · Jun 11, 1999 · SU

Device Facts

• Record ID: K991215
• Device Name: SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
• Applicant: Symtex Healthcare Corp.
• Product Code: EFQ · SU
• Decision Date: Jun 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

THIS PRODUCT IS INTENDED TO BE USED BY: - SURGEONS • NURSES • LAB TECHNICIANS • I. V. TEAM FOR THE FOLLOWING PROCEDURES: • WOUND DRESSING • DEBRIDEMENT • CLEANING • PREPPING AND SCRUBBING

Device Story

Symtex Gauze Pads and Sponges are sterile, single-use medical devices used for wound management and clinical site preparation. Operated by surgeons, nurses, lab technicians, and IV teams in clinical settings, these devices facilitate wound dressing, debridement, cleaning, and skin prepping/scrubbing. They function as passive absorbent materials to assist in clinical procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile gauze pads and sponges. Passive absorbent material. No electronic, software, or active components.

Indications for Use

Indicated for use by surgeons, nurses, lab technicians, and IV teams for wound dressing, debridement, cleaning, prepping, and scrubbing.

Submission Summary (Full Text)

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Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1999

Mr. Richard S. Wang President Symtex Healthcare Corporation 783 Pinefalls Avenue Walnut, California 91789

Re: K991215

> Trade Name: Symtex Gauze Pads and Symtex Gauze Sponges Regulatory Class: Unclassified Product Code: EFQ Dated: April 5, 1999 Received: April 9, 1999

Dear Mr. Wang:

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 (OS) 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Richard S. Wang

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,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Jun, 07 1999 10:27AM P2

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510(k) Number (if known): K991215
Device Name: Symtex Gauze Pads (I's) and Symtex Gauze Spon,
sterile (2'5)
Indications For Use:
THIS PRODUCT IS INTENDED TO BE USED BY:
- SURGEONS
• NURSES
• LAB TECHNICIANS
• I. V. TEAM
FOR THE FOLLOWING PROCEDURES:
• WOUND DRESSING
• DEBRIDEMENT
• CLEANING
• PREPPING AND SCRUBBING

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K991215 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---------------------------------------|----|-----------------------------------------------|
|---------------------------------------|----|-----------------------------------------------|