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510(k) K925406

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

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)
  • K926003 — SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER (June 7, 1993)
  • K926271 — SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO (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)

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  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
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