Cleared Traditional

K991799 - DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBI...

K991799 is an FDA 510(k) clearance for DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBI..., 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 110-day FDA review.

K991799 · Davol Inc., Sub. C. R. Bard, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
110d
Days
Class 2
Risk

K991799 is an FDA 510(k) clearance for the DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO. 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 September 13, 1999 after a review of 110 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K991799

510(k) Number K991799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1999
Decision Date September 13, 1999
Days to Decision 110 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
50d faster than avg
Panel avg: 160d · This submission: 110d
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 K991799.
AQUASENS FLUID MONITORING SYSTEM
K031213 · Davol, Inc. · Apr 2003
AQUASENS FLUID MONITORING SYSTEM
K011069 · Davol Inc., Sub. C. R. Bard, Inc. · Aug 2001
KARL STORZ HYSTEROMAT II
K000806 · KARL STORZ Endoscopy-America, Inc. · Nov 2000
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
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
K970078 · Davol Inc., Sub. C. R. Bard, Inc. · Dec 1997