Cleared Traditional

K891049 - ZEPPELIN SCISSORS

K891049 is the FDA 510(k) clearance for ZEPPELIN SCISSORS by Zinnanti Surgical Instruments, Inc.. It is a Class 1 Obstetrics & Gynecology device (product code KOH) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K891049 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
17d
Days
Class 1
Risk

K891049 is an FDA 510(k) clearance for the ZEPPELIN SCISSORS. Classified as Instrument, Manual, General Obstetric-gynecologic (product code KOH), Class I - General Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 17 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 Zinnanti Surgical Instruments, Inc. devices

Submission Details

510(k) Number K891049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date March 17, 1989
Days to Decision 17 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
143d faster than avg
Panel avg: 160d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOH Instrument, Manual, General Obstetric-gynecologic
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 - KOH Instrument, Manual, General Obstetric-gynecologic

Devices cleared under the same product code (KOH) and FDA review panel - the closest regulatory comparables to K891049.
KSEA CHARDONNES MORCELLATION KNIFE
K000212 · KARL STORZ Endoscopy-America, Inc. · Apr 2000
VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
K892693 · Zinnanti Surgical Instruments, Inc. · May 1989
NEEDLE EXTENSIONS
K891035 · Zinnanti Surgical Instruments, Inc. · Mar 1989
CAT. 4-OBSTETRICS GYNECOLOGY DEV'S
K840308 · Imm Enterprises , Ltd. · Mar 1984
INSTRUMENT CURNETT MINI-CONER BIOPSY
K781767 · C.R. Bard, Inc. · Dec 1978