Cleared Traditional

K880377 - NOVO VIVO MODEL #17140 AND #17135

K880377 is an FDA 510(k) clearance for NOVO VIVO MODEL #17140 AND #17135, manufactured by Genesis Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K880377 · Genesis Industries, Inc. · General & Plastic Surgery device
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Apr 1988
Decision
68d
Days
Class 1
Risk

K880377 is an FDA 510(k) clearance for the NOVO VIVO MODEL #17140 AND #17135. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Genesis Industries, Inc. (Spring Valley, US). The FDA issued a Cleared decision on April 4, 1988 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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.

FDA 510(k) Submission Details - K880377

510(k) Number K880377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1988
Decision Date April 04, 1988
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GAA Needle, Aspiration And Injection, Disposable

All 106
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K880377.
THORACENTISIS KIT
K894326 · Mill-Rose Laboratory · Jul 1989
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
K883014 · Sherwood Medical Co. · Jul 1988
CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM
K882105 · Dianon Systems, Inc. · Jul 1988
PRIA-KIT (TM) PRIAPISM KIT S.S.
K874000 · Canton Medical, Inc. · Dec 1987
ANCHOR BIOPSY NEEDLE
K873124 · Anchor Products Co. · Sep 1987
MEDSURG CHIBA PTC NEEDLE
K870893 · Medsurg Industries, Inc. · Mar 1987
K880377 · NOVO VIVO MODEL #17140 AND #17135
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