Home / 510(k) Clearances / K060414

510(k) K060414

KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE by Kmi Kolster Methods, Inc. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2006
Date Received
February 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

Other clearances by Kmi Kolster Methods, Inc.

  • K043591 — FEATHERLIFT EXTENDED APTOS THREAD (March 4, 2005)
  • K012236 — STARS2000 POWER CANNULA (November 19, 2001)
  • K010702 — XUB EXTERNAL ULTRASOUND (August 9, 2001)
  • K002859 — SSW-STERILE SOLUTION WARMER (November 16, 2000)
  • K991203 — IRRIGATION OR INFUSION PUMP K PUMP (October 15, 1999)

Other clearances for product code GAW

  • K233355 — Cypris eXact Suturing System (January 12, 2024)
  • K230746 — Non absorbable Surgical Polypropylene Suture (September 14, 2023)
  • K221280 — Vesseal (December 9, 2022)
  • K211178 — DURAMESH Mesh Suture (September 2, 2022)
  • K192953 — APTOS Threads – Polypropylene Surgical Sutures (August 27, 2020)
  • K193530 — Deklene MAXX (March 19, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
  • K173747 — REXLENE (December 21, 2018)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)
  • K173644 — Gazelle Polypropylene Suture and Delivery Device (February 15, 2018)