Cleared Traditional

K890380 - CERVICAL BIOPSY FORCEPS

K890380 is an FDA 510(k) clearance for CERVICAL BIOPSY FORCEPS, manufactured by Kinetic Medical Products. The device is a Class 1 Obstetrics & Gynecology device with product code HFB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K890380 · Kinetic Medical Products · Obstetrics & Gynecology device
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Feb 1989
Decision
35d
Days
Class 1
Risk

K890380 is an FDA 510(k) clearance for the CERVICAL BIOPSY FORCEPS. Classified as Forceps, Biopsy, Gynecological (product code HFB), Class I - General Controls.

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on February 27, 1989 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 884.4530 - 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 Kinetic Medical Products devices

FDA 510(k) Submission Details - K890380

510(k) Number K890380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date February 27, 1989
Days to Decision 35 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
125d faster than avg
Panel avg: 160d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

HFB Device Classification - Class 1, General Controls

Product Code HFB Forceps, Biopsy, Gynecological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4530
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 - HFB Forceps, Biopsy, Gynecological

All 8
Devices cleared under the same product code (HFB) and FDA review panel - the closest regulatory comparables to K890380.
ROTO FIT BIOPSY FORCEPS
K891043 · Zinnanti Surgical Instruments, Inc. · Mar 1989
ZSI BIOPSY FORCEPS
K891027 · Zinnanti Surgical Instruments, Inc. · Mar 1989
TISCHLER BIOPSY FORCEPS
K891034 · Zinnanti Surgical Instruments, Inc. · Mar 1989
GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS.
K851110 · The Huxley Instrument Corp. · Apr 1985