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510(k) K130591

SUPERA VERITAS by Idev Technologies, Inc. — Product Code FGE

K130591 is an FDA 510(k) premarket notification submitted by Idev Technologies, Inc. for the device "SUPERA VERITAS". The FDA issued a decision of SESU on May 2, 2013. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Idev Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
May 2, 2013
Date Received
March 7, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Idev Technologies, Inc.

  • K122546 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYST (December 7, 2012)
  • K111627 — SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY S (August 21, 2012)
  • K111766 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTE (October 19, 2011)
  • K093893 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYST (October 5, 2010)
  • K071646 — SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL (January 31, 2008)
  • K060557 — SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS0 (August 15, 2006)
  • K050926 — TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 (May 9, 2005)
  • K041374 — AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 (March 2, 2005)
  • K033188 — TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 (November 19, 2003)
  • K030504 — AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 (September 16, 2003)

Other clearances for product code FGE

  • K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-08 (June 24, 2026)
  • K253832 — Dilation Balloon Catheter (April 24, 2026)
  • K251658 — Endoflux™ Biliary & Pancreatic Stent Sets (April 16, 2026)
  • K253987 — BARE Wireguided Balloon Dilation Catheter (1235) (March 13, 2026)
  • K253132 — Single use stone retrieval balloons (March 6, 2026)
  • K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (December 29, 2025)
  • K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (December 22, 2025)
  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K251229 — EndoFix™Tissue Fixation System (August 20, 2025)
  • K243412 — ARCHIMEDES Biodegradable Pancreatic Stent (July 16, 2025)

FDA data resources