Cleared Traditional

K864219 - TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE

K864219 is an FDA 510(k) clearance for TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE, manufactured by Amedic USA. The device is a Class 2 Obstetrics & Gynecology device with product code HGL cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K864219 · Amedic USA · Obstetrics & Gynecology device
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Mar 1987
Decision
150d
Days
Class 2
Risk

K864219 is an FDA 510(k) clearance for the TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Amedic USA (Phoenix, US). The FDA issued a Cleared decision on March 27, 1987 after a review of 150 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2960 - 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 Amedic USA devices

FDA 510(k) Submission Details - K864219

510(k) Number K864219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date March 27, 1987
Days to Decision 150 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
10d faster than avg
Panel avg: 160d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGL Device Classification - Class 2, Special Controls

Product Code HGL Transducer, Ultrasonic, Obstetric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2960
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 - HGL Transducer, Ultrasonic, Obstetric

All 23
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K864219.
ANNULAR ARRAY SCANHEAD
K871856 · Advanced Technology Laboratories, Inc. · Aug 1987
BIOPSY NEEDLE GUIDE ATTACHMENT
K863797 · Elscint, Inc. · Mar 1987
280SL IMAGING SYSTEM TRANVAGINAL PROBES
K864151 · Ge Medical Systems Information Technologies · Mar 1987
ACUSON TV519 TRANSDUCER
K864578 · Acuson Computed Sonography · Mar 1987
DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
K864908 · Diasonics, Inc. · Mar 1987
7.5 MHZ ENDOVAGINAL PROBE
K870709 · Philips Ultrasound, Inc. · Mar 1987