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510(k) K830586

TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR by Keymed, Inc. — Product Code KNQ

K830586 is an FDA 510(k) premarket notification submitted by Keymed, Inc. for the device "TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Keymed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
February 23, 1983
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 Keymed, Inc.

  • K100803 — OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 (April 22, 2010)
  • K921179 — OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 (March 29, 1993)
  • K881004 — OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR (May 12, 1988)
  • K861821 — KEYMED FIBERSCOPE AUTO DISINFECTOR (February 12, 1987)
  • K864801 — THE KEYMED HI-LIGHT 250 LIGHT SOURCE (December 24, 1986)
  • K862000 — KEYMED FLEXIBLE ESOPHAGEAL DILATORS (August 12, 1986)
  • K860528 — THE KEYMED FIBERSCOPE STERILIZATION CASE (July 15, 1986)
  • K861147 — UCS-2, ULTRASONIC CLEANING SOLUTION (June 23, 1986)
  • K860704 — THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND (June 17, 1986)
  • K851149 — KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 (November 26, 1985)

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