Cleared Traditional

CORE-Trocar

K211148 · Incore Co., Ltd. · General & Plastic Surgery

Jun 2022

Decision

428d

Days

Class 2

Risk

About This 510(k) Submission

K211148 is an FDA 510(k) clearance for the CORE-Trocar, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Incore Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on June 21, 2022, 428 days after receiving the submission on April 19, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K211148 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2021
Decision Date	June 21, 2022
Days to Decision	428 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).