Home / 510(k) Clearances / K925406

510(k) K925406

BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM by Schneider Intl., Ltd. — Product Code FGE

K925406 is an FDA 510(k) premarket notification submitted by Schneider Intl., Ltd. for the device "BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 11, 1995. 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. Schneider Intl., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1995
Date Received
October 26, 1992
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 Schneider Intl., Ltd.

  • K931577 — SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI (June 23, 1993)
  • K926271 — SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO (June 7, 1993)
  • K926003 — SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER (June 7, 1993)
  • K925804 — SCHNEIDER HYDRO-SIL GUIDEWIRE (February 12, 1993)
  • K924591 — SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER (December 8, 1992)
  • K921856 — TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. (July 21, 1992)
  • K921943 — SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL (June 17, 1992)
  • K920157 — SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER (March 16, 1992)
  • K915349 — PTA BALLOON CATHETER (February 11, 1992)
  • K914009 — SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER (December 6, 1991)

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