← Product Code [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL) · K030631

# ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH (K030631)

_Prosurg, Inc. · FTL · May 19, 2003 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K030631

## Device Facts

- **Applicant:** Prosurg, Inc.
- **Product Code:** [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL.md)
- **Decision Date:** May 19, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3300
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

Zippere™ - Bioabsorbable / Non-absorbable Polymer Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the urological, gynecological or gastroentrological anatomy. This includes, but not limited to, the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolabse repair, reconstruction of the pelvic floor and secral colposuspension.

## Device Story

Zippere™ is an implantable sling and surgical mesh device; used for treatment of urinary incontinence and soft tissue reinforcement in urological, gynecological, and gastroenterological procedures. Device provides mechanical support to pelvic floor structures; aids in repair of urethral/vaginal/rectal prolapse. Operated by surgeons in clinical/OR settings. Device functions as a physical scaffold to reinforce weakened tissue; benefits patients by restoring anatomical support and correcting incontinence. No electronic or software components.

## Technological Characteristics

Implantable polymer sling and surgical mesh. Composed of bioabsorbable and/or non-absorbable materials. Mechanical device; no energy source, software, or electronic components.

## Regulatory Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an abstract symbol, possibly representing a human figure or a stylized bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2003

Mr. Ashvin Desai Manager, Regulatory Affairs ProSurg, Inc. 2195 Trade Zone Boulevard San Jose, California 95131

Re: K030631

Trade/Device Name: Zippere™ - Bioabsorbable/Non-absorbable Polymer Sling

and Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 20, 2003 Received: February 28, 2003

Dear Ms. Desai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Ashvin Desai

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## KO30631

Indications For Use:

Zippere™ - Bioabsorbable/ Non-absorbable Polymer Sling and Surgical Mesh

Zippere™ - Bioabsorbable / Non-absorbable Polymer Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the urological, gynecological or gastroentrological anatomy. This includes, but not limited to, the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolabse repair, reconstruction of the pelvic floor and secral colposuspension.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030631

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K030631](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K030631)

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