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510(k) K133420

TRANQUILL BARBED DEVICE by Surgical Specialties Corp. Dba Angiotech — Product Code NEW

K133420 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp. Dba Angiotech for the device "TRANQUILL BARBED DEVICE". The FDA issued a decision of Substantially Equivalent on November 29, 2013. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Surgical Specialties Corp. Dba Angiotech has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2013
Date Received
November 8, 2013
Clearance Type
Special
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 Surgical Specialties Corp. Dba Angiotech

  • K131224 — SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUI (May 16, 2013)
  • K130078 — QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (February 28, 2013)
  • K123877 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (January 2, 2013)
  • K123836 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (December 21, 2012)
  • K123409 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (November 20, 2012)
  • K122898 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (October 22, 2012)

Other clearances for product code NEW

  • K261988 — Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical (July 9, 2026)
  • K252171 — Barbed PDO Suture (June 12, 2026)
  • K252047 — STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices (May 18, 2026)
  • 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)

FDA data resources