Core-Sport

FDA 510(k) K220081 · Incore Co., Ltd.

Substantially Equivalent

510(k) numberK220081

Submission

Device name
Core-Sport
Applicant
Incore Co., Ltd.
Daegu, KR
Received
January 10, 2022
Decision date
September 28, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OTJ – Laparoscopic Single Port Access Device
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

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Questions and answers

When was Core-Sport cleared by the FDA?

Core-Sport (K220081) received a 510(k) decision of Substantially Equivalent on September 28, 2022, 261 days after the submission was received.

What is the product code of K220081?

The FDA product code is OTJ – Laparoscopic Single Port Access Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.