Cleared Traditional

K901288 - DAVOL SCOPE IRRIGATION SYSTEM

K901288 is an FDA 510(k) clearance for DAVOL SCOPE IRRIGATION SYSTEM, manufactured by 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 204-day FDA review.

K901288 · C.R. Bard, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Oct 1990
Decision
204d
Days
Class 2
Risk

K901288 is an FDA 510(k) clearance for the DAVOL SCOPE IRRIGATION SYSTEM. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on October 10, 1990 after a review of 204 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K901288

510(k) Number K901288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1990
Decision Date October 10, 1990
Days to Decision 204 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 161d · This submission: 204d
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 56
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K901288.
LM-100/200LOW FLOW INSUFFLATOR
K912789 · Leisegang Medical, Inc. · Sep 1991
HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
K905495 · Frigitronics, Inc. · Apr 1991
GYN-1500 HYSTEROSCOPIC INUFFLATOR
K905706 · Circon Acmi · Feb 1991
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K900908 · Zimmer, Inc. · May 1990
REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
K894259 · Washington Regulatory Services · Mar 1990
HUI MINI-FLEX
K895659 · Unimar, Inc. · Dec 1989
K901288 · DAVOL SCOPE IRRIGATION SYSTEM
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