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510(k) K010068

RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM by Rusch Intl. — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2001
Date Received
January 8, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Esophageal
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type

Other clearances by Rusch Intl.

  • K033023 — INTERMITTENT URETHRAL CATHETERS (December 23, 2003)
  • K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM (June 30, 2003)
  • K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER (June 17, 2003)
  • K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS (March 28, 2003)
  • K023964 — RUSCH MICROLARYNGEAL TUBE (December 23, 2002)
  • K021540 — RUSCH EDGAR TUBE (August 1, 2002)
  • K021764 — RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED (July 23, 2002)
  • K020714 — RUSCH FLONEIL; FLOCATH INTROGEL (July 1, 2002)
  • K010797 — RUSCH MILLER-ABBOTT TUBE (February 26, 2002)
  • K010798 — RUSCH CANTOR TUBE (February 26, 2002)

Other clearances for product code ESW

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  • K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent (October 30, 2025)
  • K251265 — Resilience Fully Covered Esophageal Stent System (July 23, 2025)
  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
  • K233837 — Agile Esophageal Stent System (April 4, 2024)
  • K240522 — Esophageal TTS Stent (March 22, 2024)
  • K223266 — Hilzo Esophageal Stents (January 16, 2024)
  • K221482 — Esophageal TTS Stent (June 22, 2022)
  • K211960 — Agile Esophageal OTW Stent System (November 22, 2021)
  • K213251 — HANAROSTENT Esophagus Asymmetric (CCC) (November 18, 2021)