Cleared Traditional

K834088 - GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING

K834088 is an FDA 510(k) clearance for GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING, manufactured by Whs Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEM cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K834088 · Whs Products, Inc. · Obstetrics & Gynecology device
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Dec 1983
Decision
92d
Days
Class 2
Risk

K834088 is an FDA 510(k) clearance for the GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING. Classified as Imager, Ultrasonic Obstetric-gynecologic (product code HEM), Class II - Special Controls.

Submitted by Whs Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 15, 1983 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2225 - 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 Whs Products, Inc. devices

FDA 510(k) Submission Details - K834088

510(k) Number K834088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1983
Decision Date December 15, 1983
Days to Decision 92 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
68d faster than avg
Panel avg: 160d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEM Device Classification - Class 2, Special Controls

Product Code HEM Imager, Ultrasonic Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2225
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 - HEM Imager, Ultrasonic Obstetric-gynecologic

All 18
Devices cleared under the same product code (HEM) and FDA review panel - the closest regulatory comparables to K834088.
MODEL U-1000 ULTRASONIC SCANNER
K851902 · Fukuda Denshi USA, Inc. · Sep 1985
INTRA VAGINAL TRANSDUCER
K853407 · Advanced Technology Laboratories, Inc. · Sep 1985
OB ULTRASOUND LINEAR SCANNER 630
K842261 · Ge Medical Systems Information Technologies · Sep 1984
SONICOMP
K833488 · Sonicaid, Inc. · Nov 1983
DATASON DB ULTRASOUND IMAGING SYSTEM
K810305 · General Electric Co. · Mar 1981
ULTRASONIC IMAGER
K780876 · Air-Shields, Inc. · Jun 1978