ISOLYER (4X4, 8PLY)
Device Facts
| Record ID | K940755 |
|---|---|
| Device Name | ISOLYER (4X4, 8PLY) |
| Applicant | Isolyer Co. |
| Product Code | NAB · General, Plastic Surgery |
| Decision Date | May 2, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4014 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
April 9, 2024
Isolyer Company, Inc.
Travis Honeycutt
Executive Vice President
Isolyer Company, Inc.
4320 International Boulevard, Northwest
Norcross, Georgia 30093
Re: K940755
Trade/Device Name: Isolyer (4x4, 8 Ply)
Regulation Number: 21 CFR 878.4014
Regulation Name: Nonresorbable gauze/sponge for external use
Regulatory Class: Class I
Product Code: NAB
Dear Travis Honeycutt:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 2, 1994. Specifically, FDA is updating this SE because FDA has better categorized your device technology under product code NAB.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, yu-chieh.chiu@fda.hhs.gov.
Sincerely,
Yu-Chieh Chiu -S
Yu-Chieh Chiu, Ph.D.
Assistant Director
DHT4B: Division of Infection Control
and Plastic Surgery Devices
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 2 1994
Food and Drug Administration
1390 Piccard Drive
Rockville MD 20850
Mr. Travis Honeycutt
Executive Vice President
Isolyser Company, Inc.
4320 International Boulevard, Northwest
Norcross, Georgia 30093
Re: K940754
Isolyser (4X4, 12 Ply)
K940755
Isolyser (4X4, 8 Ply)
Regulatory Class: Unclassified
K940756
Isolyser (X-Ray Detectable)
K940757
Isolyser (4X18 X-Ray Detectable)
K940762
Isolyser (18X18 X-Ray Detectable)
K940763
Isolyser (8X4, 12 Ply X-ray Detectable)
Regulatory Class: II
Dated: April 22, 1994
Received: April 25, 1994
Dear Mr. Honeycutt:
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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and 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. In addition, the Food and Drug Administration (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
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Page 2 - Mr. Travis Honeycutt
the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations.
This letter immediately will allow you to begin marketing your device as described. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice on the labeling for your device, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-326) at (301) 594-4639. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Paul R. Beninger
Paul R. Beninger, M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
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