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510(k) K830991

ESOPHAGEAL BOUGIES by Medovations, Inc. — Product Code KNQ

K830991 is an FDA 510(k) premarket notification submitted by Medovations, Inc. for the device "ESOPHAGEAL BOUGIES". The FDA issued a decision of Substantially Equivalent on Jun 2, 1983. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Medovations, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 2, 1983
Date Received
Mar 29, 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 Medovations, Inc.

  • K142068 — BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING (Mar 10, 2015)
  • K002363 — MEDOVATIONS ESOPHAGEAL DILATOR (Nov 1, 2000)
  • K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (Feb 2, 1998)
  • K924646 — OVER THE GUIDEWIRE DILATATION SYSTEM (Dec 5, 1994)
  • K913678 — TROCAR CATHETER (Dec 16, 1991)
  • K905478 — YANKAUER SUCTION DEVICE (Dec 19, 1990)
  • K874309 — URETHAL CATHETER (Dec 7, 1987)
  • K864963 — STOMACH EVACULATOR - EWALD STYLE (Oct 14, 1987)
  • K864962 — OBERTO MOUTH PROP (Feb 19, 1987)
  • K864964 — 5 - IN - 1 CONNECTOR (Jan 20, 1987)

Other clearances for product code KNQ

  • K122924 — CRE FIXED WIRE BALLON DILATION CATHETER (Oct 24, 2012)
  • K093236 — ETHICON ENDO-SURGERYOPTICAL DILATOR (Nov 10, 2009)
  • K090183 — HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON (Sep 25, 2009)
  • K082995 — SMART DILATOR (Feb 6, 2009)
  • K061937 — COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (Dec 1, 2006)
  • K061787 — MAXFORCE TTS SINGLE-USE BALLOON DILATOR (Sep 21, 2006)
  • K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED (Apr 11, 2006)
  • K043605 — INSCOPE 3-STAGE BALLOON DILATOR (Feb 4, 2005)
  • K033936 — BARD ELIMINATOR PET BALLOON DILATORS (Jan 14, 2004)
  • K031147 — OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR (Jan 12, 2004)

FDA data resources