Home / 510(k) Clearances / K953609

510(k) K953609

PRODEK by Sutures , Ltd. — Product Code GAW

K953609 is an FDA 510(k) premarket notification submitted by Sutures , Ltd. for the device "PRODEK". The FDA issued a decision of SN on January 31, 1996. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Sutures , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 31, 1996
Date Received
August 2, 1995
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 Sutures , Ltd.

  • K990432 — SURGISORB (May 27, 1999)
  • K943218 — CHROMIC CATGUT (December 5, 1994)
  • K943217 — PLAIN CATGUT (December 5, 1994)
  • K943223 — SURGIDEK B (December 5, 1994)
  • K943220 — SUTULENE (December 5, 1994)
  • K943222 — SURGIDEK S (December 5, 1994)
  • K943627 — SURGISILK (December 5, 1994)
  • K943221 — SURGIBOND (December 5, 1994)
  • K943216 — SURGIDEK (December 5, 1994)
  • K865038 — SURGISTEEL (June 30, 1987)

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