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510(k) K932015

TRI-MED INFLATABLE ESOPHAGEAL DILATOR by Tri-Med Specialties, Inc. — Product Code KNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1994
Date Received
April 23, 1993
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

Other clearances by Tri-Med Specialties, Inc.

  • K971615 — PATTISON ESOPHAGEAL DILATOR (July 24, 1997)
  • K970890 — #ES-32 SUCTION CATHETER 32 FR. (May 23, 1997)
  • K970982 — T-RX RETRIEVAL FORCEPS (May 9, 1997)
  • K942918 — TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (February 28, 1995)
  • K950574 — NEEDLE/CANNULA (February 24, 1995)
  • K934348 — TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (December 23, 1994)
  • K945160 — PARACENTESIS NEEDLES/CANNULAS (November 14, 1994)
  • K924549 — TRI-MED QUICK-STEP(TM) RECTAL TUBE (February 10, 1994)
  • K932652 — TRI-MED PARACENTESIS TRAY (November 24, 1993)
  • K931201 — TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (September 28, 1993)

Other clearances for product code KNQ

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  • K093236 — ETHICON ENDO-SURGERYOPTICAL DILATOR (November 10, 2009)
  • 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)
  • K031147 — OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR (January 12, 2004)