Cleared Traditional

K901530 - WALLACE INTRAUTERINE INSEMINATION CATHETER

K901530 is an FDA 510(k) clearance for WALLACE INTRAUTERINE INSEMINATION CATHETER, manufactured by Gynescope Corp.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K901530 · Gynescope Corp. · Dental device
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Jul 1990
Decision
112d
Days
Class 2
Risk

K901530 is an FDA 510(k) clearance for the WALLACE INTRAUTERINE INSEMINATION CATHETER. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Gynescope Corp. (Willoughby, US). The FDA issued a Cleared decision on July 23, 1990 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - the FDA dental device regulatory 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Gynescope Corp. devices

FDA 510(k) Submission Details - K901530

510(k) Number K901530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1990
Decision Date July 23, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 Dental devices follow this clearance model.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 552
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K901530.
ARGENCO NORDIC
K903274 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 28
K903278 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 27
K903280 · Argen Precious Metals, Inc. · Aug 1990
SILVER-FREE CERAMIC SOLDER (SFCS)
K902372 · Leach and Dillon Co., Inc. · Jun 1990
200 SILHOUETTE LINE (SL) CERAMIC SOLDER
K902373 · Leach and Dillon Co., Inc. · Jun 1990
DEGUSSA STOPFGOLD (DEGUSSA DIRECT-FILLING GOLD)
K902387 · Degussa AG · Jun 1990