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510(k) K131224

SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE by Surgical Specialties Corp. Dba Angiotech — Product Code GAW

K131224 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp. Dba Angiotech for the device "SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE". The FDA issued a decision of Substantially Equivalent on May 16, 2013. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Surgical Specialties Corp. Dba Angiotech has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2013
Date Received
April 30, 2013
Clearance Type
Special
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 Surgical Specialties Corp. Dba Angiotech

  • K133420 — TRANQUILL BARBED DEVICE (November 29, 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 GAW

  • K253572 — STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATA (March 27, 2026)
  • 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)

FDA data resources