Home / 510(k) Clearances / K113744

510(k) K113744

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) by Angiotech — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2012
Date Received
December 20, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

Other clearances by Angiotech

  • K151112 — Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design (September 10, 2015)
  • DEN090007 — BIO-SEAL LUNG BIOPSY TRACT SYSTEM (December 19, 2012)
  • K120827 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) (July 13, 2012)
  • K113800 — QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE (January 20, 2012)
  • K073672 — SKATER BILIARY CATHETER (January 24, 2008)
  • K070610 — SKATER BILIARY CATHETER (June 21, 2007)

Other clearances for product code NEW

  • K243897 — PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Su (November 12, 2025)
  • K251414 — Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) (October 20, 2025)
  • K250107 — V-soft Line™ Barbed Surgical Suture (Various) (October 15, 2025)
  • K252644 — PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PIN (September 23, 2025)
  • K250977 — Suture-TOOL System (April 28, 2025)
  • K242835 — Suture-TOOL System (January 22, 2025)
  • K242571 — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 (September 27, 2024)
  • K232246 — 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; (April 25, 2024)
  • K240389 — Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (March 27, 2024)
  • K220549 — MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift M (March 7, 2023)