Cleared Traditional

K902019 - MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS

K902019 is an FDA 510(k) clearance for MODIFIED METAL SPECULUM & SPECIAL BULLE..., manufactured by Gynescope Corp.. The device is a Class 1 Obstetrics & Gynecology device with product code HDF cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K902019 · Gynescope Corp. · Obstetrics & Gynecology device
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Jun 1990
Decision
35d
Days
Class 1
Risk

K902019 is an FDA 510(k) clearance for the MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS. Classified as Speculum, Vaginal, Metal (product code HDF), Class I - General Controls.

Submitted by Gynescope Corp. (Willoughby, US). The FDA issued a Cleared decision on June 7, 1990 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4520 - 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 Gynescope Corp. devices

FDA 510(k) Submission Details - K902019

510(k) Number K902019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1990
Decision Date June 07, 1990
Days to Decision 35 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
125d faster than avg
Panel avg: 160d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

HDF Device Classification - Class 1, General Controls

Product Code HDF Speculum, Vaginal, Metal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4520
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HDF Speculum, Vaginal, Metal

All 9
Devices cleared under the same product code (HDF) and FDA review panel - the closest regulatory comparables to K902019.
VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
K926429 · Thomasville Medical Assoc. · Feb 1994
MIYA SPECULUM
K891041 · Zinnanti Surgical Instruments, Inc. · Mar 1989
LASER SPECULA
K891044 · Zinnanti Surgical Instruments, Inc. · Mar 1989
VAGINAL SPECULUM
K890375 · Kinetic Medical Products · Feb 1989
WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL
K853640 · Downs Surgical , Ltd. · Oct 1985
61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA
K851799 · Artiberia · May 1985