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510(k) K021672

PANCREATIC DRAINAGE TUBE by Aomori Olympus Co., Ltd. — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2003
Date Received
May 21, 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 Aomori Olympus Co., Ltd.

  • K042160 — SONOSURG TROCAR (January 25, 2005)
  • K041566 — SONOSURG ULTRASONIC SURGICAL SYSTEM (September 8, 2004)
  • K033333 — SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B (November 14, 2003)
  • K031523 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (October 1, 2003)
  • K031710 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (August 29, 2003)
  • K022446 — MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C (March 28, 2003)

Other clearances for product code FGE

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  • 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)