Cleared Traditional

K891048 - OVUM FORCEPS-BARRET

K891048 is the FDA 510(k) clearance for OVUM FORCEPS-BARRET by Zinnanti Surgical Instruments, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code KNA) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K891048 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology device
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Mar 1989
Decision
22d
Days
Class 2
Risk

K891048 is an FDA 510(k) clearance for the OVUM FORCEPS-BARRET,JAVERTS,WILLET,HANSEN,COREY,MC. Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on March 22, 1989 after a review of 22 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 Zinnanti Surgical Instruments, Inc. devices

Submission Details

510(k) Number K891048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date March 22, 1989
Days to Decision 22 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
138d faster than avg
Panel avg: 160d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNA Instrument, Manual, Specialized Obstetric-gynecologic
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 - KNA Instrument, Manual, Specialized Obstetric-gynecologic

All 27
Devices cleared under the same product code (KNA) and FDA review panel - the closest regulatory comparables to K891048.
CORSON MYOMA GRASPING FORCEPS
K891399 · Zinnanti Surgical Instruments, Inc. · Mar 1989
MIYA HOOK
K891045 · Zinnanti Surgical Instruments, Inc. · Mar 1989
SOPHER AND BIERER OVUM FORCEPS
K891046 · Zinnanti Surgical Instruments, Inc. · Mar 1989
MICRO SURGERY FORCEPS
K891039 · Zinnanti Surgical Instruments, Inc. · Mar 1989
MICRO SURGERY SCISSORS
K891040 · Zinnanti Surgical Instruments, Inc. · Mar 1989
MICRO SURGERY NEEDLE HOLDERS
K891042 · Zinnanti Surgical Instruments, Inc. · Mar 1989