Cleared Traditional

K903744 - PHYSICIAN'S CHOICE

K903744 is an FDA 510(k) clearance for PHYSICIAN'S CHOICE, manufactured by Advance Medical Device, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K903744 · Advance Medical Device, Inc. · Obstetrics & Gynecology device
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Sep 1990
Decision
27d
Days
Class 2
Risk

K903744 is an FDA 510(k) clearance for the PHYSICIAN'S CHOICE. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Advance Medical Device, Inc. (Ontario L3y 4v8, Canada, CA). The FDA issued a Cleared decision on September 12, 1990 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advance Medical Device, Inc. devices

FDA 510(k) Submission Details - K903744

510(k) Number K903744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1990
Decision Date September 12, 1990
Days to Decision 27 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
133d faster than avg
Panel avg: 160d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIB Device Classification - Class 2, Special Controls

Product Code HIB Speculum, Vaginal, Nonmetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HIB Speculum, Vaginal, Nonmetal

All 14
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K903744.
KLEENSPEC
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K894957 · Zinnanti Surgical Instruments, Inc. · Oct 1989
GYNECOLOGIC EXAMINATION KIT
K894489 · A & A Medical, Inc. · Oct 1989
EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM
K882605 · Buckman Co., Inc. · Sep 1988