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510(k) K910671

MODEL GS-4700 COMMON DUCT STONE REMOVING KIT by Solos Endoscopy, Inc. — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1991
Date Received
February 15, 1991
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 Solos Endoscopy, Inc.

  • K983538 — MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILIT (November 6, 1998)
  • K900957 — GS-2100 HOOK SUTURE SCISSOR, 5MM (April 18, 1990)
  • K900963 — GS-4350 TROCAR ONLY, 5.5MM (April 18, 1990)
  • K900956 — GS-7100 CHOLANGIOGRAM CLAMP, 5MM (April 18, 1990)
  • K900947 — GS-1000 GRASPING FORCEP, 5MM, INSULATED (April 18, 1990)
  • K900958 — GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM (April 18, 1990)
  • K900961 — GS-4100 REDUCER SLEEVE, 5MM TO 3MM (April 18, 1990)
  • K900953 — GS-5000 SPATULA SUCTION/COAGULATOR, 5MM (April 18, 1990)
  • K900951 — GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP (April 18, 1990)
  • K900962 — GS-4300 CANNULA AND TROCAR, 5.5MM (April 18, 1990)

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)