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510(k) K970078

HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM by Davol Inc., Sub. C. R. Bard, Inc. — Product Code HIG

K970078 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 11, 1997. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Davol Inc., Sub. C. R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1997
Date Received
January 9, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type

Other clearances by Davol Inc., Sub. C. R. Bard, Inc.

  • K101851 — VENTRALIGHT ST MESH (July 15, 2010)
  • K092032 — BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117 (December 8, 2009)
  • K081010 — BARD 3DMAX MESH (October 7, 2008)
  • K061754 — BARD COMPOSITE L/P MESH (October 23, 2006)
  • K061314 — BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH (June 2, 2006)
  • K051848 — SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, (August 11, 2005)
  • K050610 — SALUTE FIXATION SYSTEM (May 25, 2005)
  • K011069 — AQUASENS FLUID MONITORING SYSTEM (August 16, 2001)
  • K003674 — NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORB (December 8, 2000)
  • K991799 — DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO (September 13, 1999)

Other clearances for product code HIG

  • K261706 — Endomat Select (UP220) (July 16, 2026)
  • K251273 — Asurys Fluid Management System (March 27, 2026)
  • K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System (July 25, 2024)
  • K210628 — X-FLO Fluid Management System (November 4, 2021)
  • K201355 — Endomat Select, IBS Shaver Software, License (July 22, 2020)
  • K180735 — Endomat Select (October 31, 2018)
  • K180825 — Fluent Fluid Management System (August 3, 2018)
  • K173489 — GYN-Pump PH304 (March 28, 2018)
  • K172040 — Aquilex Fluid Control System AQL-100S (February 5, 2018)
  • K172048 — FluidSmart (September 5, 2017)

FDA data resources