Cleared Traditional

K112400 - SMARTSHEARS

K112400 is an FDA 510(k) clearance for SMARTSHEARS, manufactured by Nuscience Consulting and Management Group, LLC. The device is a Class 1 General & Plastic Surgery device with product code FZT cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K112400 · Nuscience Consulting and Management Group, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
24d
Days
Class 1
Risk

K112400 is an FDA 510(k) clearance for the SMARTSHEARS. Classified as Cutter, Surgical (product code FZT), Class I - General Controls.

Submitted by Nuscience Consulting and Management Group, LLC (Fleming Island, US). The FDA issued a Cleared decision on September 12, 2011 after a review of 24 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.

View all Nuscience Consulting and Management Group, LLC devices

FDA 510(k) Submission Details - K112400

510(k) Number K112400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2011
Decision Date September 12, 2011
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

FZT Device Classification - Class 1, General Controls

Product Code FZT Cutter, Surgical
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 - FZT Cutter, Surgical

All 34
Devices cleared under the same product code (FZT) and FDA review panel - the closest regulatory comparables to K112400.
AUTO SUTURE DISPOSABLE SURGICAL TROCAR*
K890818 · United States Surgical, A Division of Tyco Healthc · May 1989
SCISSORS, VARIOUS
K822448 · J. Sklar Mfg. Co., Inc. · Sep 1982
SURGICAL SCISSORS, SET OF 3
K821632 · Fred Sammons, Inc. · Jun 1982
CONPHAR WIRE CUTTING SCISSORS
K821350 · Conphar, Inc. · May 1982
CONPHAR DISSECTING SCISSORS
K821351 · Conphar, Inc. · May 1982
CONPHAR IRIS SCISSORS
K821352 · Conphar, Inc. · May 1982