Cleared Traditional

K894259 - REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA

K894259 is an FDA 510(k) clearance for REGISTER, manufactured by Washington Regulatory Services. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K894259 · Washington Regulatory Services · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
258d
Days
Class 2
Risk

K894259 is an FDA 510(k) clearance for the REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Washington Regulatory Services (Ringoes, US). The FDA issued a Cleared decision on March 5, 1990 after a review of 258 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 - K894259

510(k) Number K894259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1989
Decision Date March 05, 1990
Days to Decision 258 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 161d · This submission: 258d
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 K894259.
GYN-1500 HYSTEROSCOPIC INUFFLATOR
K905706 · Circon Acmi · Feb 1991
DAVOL SCOPE IRRIGATION SYSTEM
K901288 · C.R. Bard, Inc. · Oct 1990
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K900908 · Zimmer, Inc. · May 1990
HUI MINI-FLEX
K895659 · Unimar, Inc. · Dec 1989
HYSTEROFLATOR 2001
K895907 · Cabot Medical Corp. · Dec 1989
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
K892001 · Dexide, Inc. · Jun 1989
K894259 · REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
Download PDF Washington Regulatory…