KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE— 510(k) K060414

Clearance details

Applicant

Kmi Kolster Methods, Inc.

Product code

Code GAW

Device class

Class 2

Regulation

21 CFR 878.5010

Advisory panel

General, Plastic Surgery

Date received

2006-02-16

Decision date

2006-10-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Corona, CA, US

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• K043591 — FEATHERLIFT EXTENDED APTOS THREAD2005-03-04
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• K010702 — XUB EXTERNAL ULTRASOUND2001-08-09
• K002859 — SSW-STERILE SOLUTION WARMER2000-11-16
• K991203 — IRRIGATION OR INFUSION PUMP K PUMP1999-10-15

Death

66

Injury

1,616

Malfunction

10,428

Total

12,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2208-2015 — Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.Class II·Terminated·Silhouette Lift, Inc.·20150702

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060414.