CPR LAP SPONGES

K960236 · Custom Pack Reliability · GDY · Mar 28, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960236
• Device Name: CPR LAP SPONGES
• Applicant: Custom Pack Reliability
• Product Code: GDY · General, Plastic Surgery
• Decision Date: Mar 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4450
• Device Class: Class 1

Intended Use

Removal of suture from the epidermis.

Device Story

The Suture Removal Kit is a procedural kit used for the removal of sutures from the epidermis. It is intended for prescription use by healthcare professionals in clinical settings. The kit contains medical device components that are either legally marketed or determined to be substantially equivalent. The device facilitates the clinical task of suture removal, aiding in post-surgical wound management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Procedural kit containing medical device components. Specific materials, dimensions, and sterilization methods are not detailed in the provided documentation.

Indications for Use

Indicated for the removal of sutures from the epidermis.

Regulatory Classification

Identification

Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.

Reference Devices

• Lap Sponges (K960236)
• Basic Set-Up Tray (K960208)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 9, 2024

Custom Pack Reliability
Richard Ellwood
President
4207 Vineland Road, M-1
Orlando, Florida 32811

Re: K960236
Trade/Device Name: CPR Lap Sponges
Regulation Number: 21 CFR 878.4450
Regulation Name: Nonabsorbable gauze for internal use
Regulatory Class: Class I
Product Code: GDY

Dear Richard Ellwood:

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 March 28, 1996. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code GDY.

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, [e-mail].

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
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Richard L. Ellwood
President
Custom Pack Reliability
4207 Vineland Road, M-1
Orlando, Florida 32811

MAR 28 1996

Re: K960236
Lap Sponges
Regulatory Class: I
Product Code: GER
K960208
Basic Set-Up Tray
K960238
CPR Suture Removal Kit
Regulatory Class: II
Product Code: FRG
Dated: February 15, 1996
Received: February 23, 1996

Dear Mr. Ellwood:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the Lap Sponges, Basic Set-Up Tray and CPR Suture Removal Kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kits. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Mr. Richard L. Ellwood

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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.

This letter immediately will allow you to begin marketing your devices as described in your 510(k) premarket notifications. An FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and permits your devices to proceed to the market, but it does not mean that FDA approves your devices. Therefore, you may not promote or in any way represent your devices or their labeling as being approved by FDA. If you desire specific advice for your devices on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at [phone]. 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 at [phone].

Sincerely yours,

Kimber C. Richter, M.D.
Acting Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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9

K960238

Invoice Number (if known):

Device Name: Suture Removal Kit

Indications For Use:
Removal of suture from the epidermis.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K960238

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)