Cleared Traditional

K210478 - 8mm Monopolar Curved Scissors (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210478 · Iconocare Health · General & Plastic Surgery device
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Sep 2022
Decision
588d
Days
Class 2
Risk

K210478 is an FDA 510(k) clearance for the 8mm Monopolar Curved Scissors. Classified as System, Surgical, Computer Controlled Instrument, Remanufactured (product code QSM), Class II - Special Controls.

Submitted by Iconocare Health (Scottsdale, US). The FDA issued a Cleared decision on September 30, 2022 after a review of 588 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Iconocare Health devices

Submission Details

510(k) Number K210478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2021
Decision Date September 30, 2022
Days to Decision 588 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
474d slower than avg
Panel avg: 114d · This submission: 588d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QSM System, Surgical, Computer Controlled Instrument, Remanufactured
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition As Intended With The Originally Cleared Instrument.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QSM System, Surgical, Computer Controlled Instrument, Remanufactured

All 7
Devices cleared under the same product code (QSM) and FDA review panel - the closest regulatory comparables to K210478.
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8mm Monopolar Curved Scissors (470179)
K242610 · Iconocare Health · Mar 2025