Home / 510(k) Clearances / K030053

510(k) K030053

JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 by Jomed AG — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2003
Date Received
December 23, 2002
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 Jomed AG

  • K031346 — JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 (June 23, 2003)
  • K031148 — IN-VISION IMAGING SYSTEM (May 28, 2003)
  • K031277 — JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M (May 14, 2003)
  • K022762 — JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG14 (December 16, 2002)
  • K021219 — SMARTWIRE/SMARTMAP PRESSURE SYSTEM (May 17, 2002)
  • K020854 — MODIFICATION TO FOX PTA CATHETER (April 11, 2002)
  • K010838 — FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A1400 (June 21, 2001)
  • K003938 — TRAK BACK II (January 18, 2001)

Other clearances for product code FGE

  • 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)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
  • K241888 — Single-use Balloon Dilatation Catheter (December 20, 2024)