KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE

• K Number: K060414
• Device Name: KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
• Manufacturer: KMI KOLSTER METHODS, INC.
• Date Cleared: 2006-10-23 ( 249 days)
• Product Code: GAW , GAM
• Regulation Number: 878.5010
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The Featherlift silhouette Suture is indicated for use in mid-face suspension surgery to fixate the cheek sub dermis in an elevated position.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the "Featherlift Silhouette Suture." It confirms that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory document does not contain acceptance criteria or a study describing device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance data.

Regulation Number and Section

§ 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.