Cleared Traditional

K864908 - DIASONICS TRANSVAGINAL

K864908 is an FDA 510(k) clearance for DIASONICS TRANSVAGINAL, manufactured by Diasonics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGL cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K864908 · Diasonics, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
102d
Days
Class 2
Risk

K864908 is an FDA 510(k) clearance for the DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Diasonics, Inc. (Milipitas, US). The FDA issued a Cleared decision on March 27, 1987 after a review of 102 days - within the typical 510(k) review window.

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 Diasonics, Inc. devices

FDA 510(k) Submission Details - K864908

510(k) Number K864908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1986
Decision Date March 27, 1987
Days to Decision 102 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
58d faster than avg
Panel avg: 160d · This submission: 102d
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 18
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K864908.
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
7.5 MHZ ENDOVAGINAL PROBE
K870709 · Philips Ultrasound, Inc. · Mar 1987
TRANSVAGINAL PROBE, MODEL ED65M-TV
K861371 · Elscint, Inc. · Jul 1986
TRANSVAGINAL TRANSDUCER, 5MHZ
K860234 · Philips Medical Systems, Inc. · May 1986