Cleared Traditional

K970078 - HYDROFLOEX HD HYSTEROSCOPIC DISTENTION ...

K970078 is an FDA 510(k) clearance for HYDROFLOEX HD HYSTEROSCOPIC DISTENTION ..., manufactured by Davol Inc., Sub. C. R. Bard, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K970078 · Davol Inc., Sub. C. R. Bard, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
336d
Days
Class 2
Risk

K970078 is an FDA 510(k) clearance for the HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Davol Inc., Sub. C. R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on December 11, 1997 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Davol Inc., Sub. C. R. Bard, Inc. devices

FDA 510(k) Submission Details - K970078

510(k) Number K970078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1997
Decision Date December 11, 1997
Days to Decision 336 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 160d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIG Device Classification - Class 2, Special Controls

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIG Insufflator, Hysteroscopic

All 37
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K970078.
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
K991799 · Davol Inc., Sub. C. R. Bard, Inc. · Sep 1999
HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000
K982867 · Davol Inc., Sub. C. R. Bard, Inc. · Feb 1999
HYS-SURGIFLATOR 150P
K983889 · W.O.M. World of Medicine GmbH · Jan 1999
HYSTERO CO2-PNEU 2221
K964136 · Richard Wolf Medical Instruments Corp. · Jan 1997
KARL STORZ MODEL 203020 20 EQUIMAT
K961091 · KARL STORZ Endoscopy-America, Inc. · Oct 1996
HYS-SURGIMAT
K934866 · W.O.M. World of Medicine GmbH · Oct 1995