(66 days)
The Featherlift™ Extended Length Aptos Thread is indicated for use in midface suspension surgery to fixate the cheek sub dermis in an elevated position.
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This document is a marketing clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, study details, or performance data for the device. Therefore, I cannot extract the requested information from the provided text.
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MAR 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Keith Davis KMI Kolster Methods, Inc. 3185 Palisades Drive Corona, California 92882
Re: K043591
K043591
Trade/Device Name: Featherlift™ Extended Length Aptos Thread Regulation Number: 21 CFR 878.5010 Regulation Name: Non-Absorbable synthetic polypropylene suture Regulatory Class: II Product Code: GAW Dated: December 28, 2004 Received: January 12, 2005
Dear Mr. Davis:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premaince is substantially equivalent (for the indications
referenced above and have determined the device is subser marketed in intersta referenced above and nave determined the acresed predicate devices marketed in interstate for use stated in the encrosule) to regary maneted por the Medical Device Amendments, or to commerce prior to May 28, 1776, the enasations with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMA devices that have been recassince in acceraanse what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premaining of the Act . and Cosmelle Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions ba You may, therefore, market the device, bacycer courements for annual registration. Iisting of
general controls provisions of the Act include requirements for annual registrat general controls provisions of the Fee networks and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) nits. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional connerior Linestigations. Title 21, Parts 800 to 898. In addition, FDA may be found in the Coast of reach sconcerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial cquivalence determination docs not mean Please be advised that 1177 s issuation of a crevice complies with other requirements of the Act that ITDA has made a docemination administered by other Federal agencies. You must of any reactal statutes and regulations adminities of a limited to: registration and listing (21 comply with an the 7te stequirements,01); good manufacturing practice requirements as set CFK Fart 807), adomig (21 OFR Part 820); golder, and 820); and 1f applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Keith Davis
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manceing your and equivalence of your device to a legally premits that nother in the Privating of east on 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 desire specific advice for your ac not on our sales note the regulation entitled.
contact the Office of Compliance at (240) 276-0115. Also, please note the regulation Colliact the Office of Complance at (210) = if = = = = 807.97). You may obtain Misoranding of Icrerchee to premainters in the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C Purist
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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Section 5 Revised
Indications for Use
510(k) Number (K043591)
Device Name: Featherlift™ Extended Length Aptos Thread
Indications for Use:
The Featherlift™ Extended Length Aptos Thread is indicated for use in midface suspension surgery to fixate the cheek sub dermis in an elevated position.
Prescription Use (Part 21 CFR 801 Subpart D) And/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) miriam C. Shoros (Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
K6435 510(k) Number
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
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.(b)
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.