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510(k) K031147

OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR by Ethicon Endo-Surgery, Inc. — Product Code KNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2004
Date Received
April 10, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Esophageal
Device Class
Class II
Regulation Number
876.5365
Review Panel
GU
Submission Type

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Other clearances for product code KNQ

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  • K090183 — HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON (September 25, 2009)
  • K082995 — SMART DILATOR (February 6, 2009)
  • K061937 — COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (December 1, 2006)
  • K061787 — MAXFORCE TTS SINGLE-USE BALLOON DILATOR (September 21, 2006)
  • K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED (April 11, 2006)
  • K043605 — INSCOPE 3-STAGE BALLOON DILATOR (February 4, 2005)
  • K033936 — BARD ELIMINATOR PET BALLOON DILATORS (January 14, 2004)
  • K023907 — CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BA (December 18, 2002)