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510(k) K971615

PATTISON ESOPHAGEAL DILATOR by Tri-Med Specialties, Inc. — Product Code KNQ

K971615 is an FDA 510(k) premarket notification submitted by Tri-Med Specialties, Inc. for the device "PATTISON ESOPHAGEAL DILATOR". The FDA issued a decision of Substantially Equivalent on July 24, 1997. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Tri-Med Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1997
Date Received
May 2, 1997
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.

  • 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)
  • K932015 — TRI-MED INFLATABLE ESOPHAGEAL DILATOR (February 3, 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

  • K122924 — CRE FIXED WIRE BALLON DILATION CATHETER (October 24, 2012)
  • 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)

FDA data resources