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510(k) K082995

SMART DILATOR by Safestitch Medical — Product Code KNQ

K082995 is an FDA 510(k) premarket notification submitted by Safestitch Medical for the device "SMART DILATOR". The FDA issued a decision of Substantially Equivalent on February 6, 2009. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2009
Date Received
October 8, 2008
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 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)
  • 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)
  • K023907 — CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BA (December 18, 2002)

FDA data resources