UNIPRO

K042283 · United Medical Industries Co. , Ltd. · GAW · Dec 1, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042283
• Device Name: UNIPRO
• Applicant: United Medical Industries Co. , Ltd.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

UniPro is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

UniPro is a nonabsorbable polypropylene surgical suture; used for soft tissue approximation and ligation; indicated for cardiovascular, ophthalmic, and neurological procedures; intended for use by surgeons in clinical settings; provides mechanical wound closure; benefits patient through secure tissue approximation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nonabsorbable polypropylene surgical suture; Class II device; 21 CFR 878.5010; sterile.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients requiring cardiovascular, ophthalmic, or neurological surgical procedures.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2004

Mr. Mohammed Azeez M.Sc., Quality Assurance Manager United Medical Industries Co. Ltd. (UNIMED) P.O. Box- 51871, Riyadh - 11553 Kingdom of Saudi Arabia

Re: K042283

Trade/Device Name: UniPro Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable ploypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: November 7, 2004 Received: November 9, 2004

Dear Mr. Azeez:

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 (QS) 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. Mohammed Azeez M.Sc.,

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in yours of substantial equivalence of your device to a legally prematics notification. The 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 If you dome specific and Compliance at [phone]. 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 from the Division of Small other general micronal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam 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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## Indications for Use

510(k) Number (if known):

KO42283

Device Name:

UniPro

Indications for Use:

UniPro is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

iriam C. Provost

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

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