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510(k) K881478

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS by Keymed (Medical & Industrial Equipment), Ltd. — Product Code KNQ

K881478 is an FDA 510(k) premarket notification submitted by Keymed (Medical & Industrial Equipment), Ltd. for the device "MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS". The FDA issued a decision of Substantially Equivalent on September 14, 1988. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Keymed (Medical & Industrial Equipment), Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1988
Date Received
April 6, 1988
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 (Medical & Industrial Equipment), Ltd.

  • K193250 — Irrigation Tubing with CO2 or Air (April 6, 2020)
  • K100899 — OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 (September 13, 2010)
  • K011725 — OLYMPUS SUCTION PUMP, MODEL KV-5 (August 31, 2001)
  • K000948 — OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 (May 12, 2000)
  • K962528 — OLYMPUS MOBILE CHAIR/COUCH (December 12, 1996)
  • K930852 — OLYMPUS SUCTION PUMP MODEL KV-4 (March 31, 1994)

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