Cleared Traditional

CORE-SPORT (K220081) - FDA 510(k) Clearance

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

K220081 · Incore Co., Ltd. · General & Plastic Surgery device
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Sep 2022
Decision
261d
Days
Class 2
Risk

K220081 is an FDA 510(k) clearance for the CORE-SPORT. Classified as Laparoscopic Single Port Access Device (product code OTJ), Class II - Special Controls.

Submitted by Incore Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 28, 2022 after a review of 261 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Incore Co., Ltd. devices

Submission Details

510(k) Number K220081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2022
Decision Date September 28, 2022
Days to Decision 261 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
146d slower than avg
Panel avg: 115d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OTJ Laparoscopic Single Port Access Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery.
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 - OTJ Laparoscopic Single Port Access Device

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