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510(k) K220081

CORE-SPORT by Incore Co., Ltd. — Product Code OTJ

K220081 is an FDA 510(k) premarket notification submitted by Incore Co., Ltd. for the device "CORE-SPORT". The FDA issued a decision of Substantially Equivalent on September 28, 2022. The device falls under product code OTJ (Laparoscopic Single Port Access Device), a Class II device regulated under 21 CFR 876.1500. Incore Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2022
Date Received
January 10, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscopic Single Port Access Device
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

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

Other clearances by Incore Co., Ltd.

  • K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) (April 19, 2024)
  • K221054 — CORE-INJECTOR (December 21, 2022)
  • K220846 — CORE-SNARE (November 21, 2022)
  • K213338 — CORE-CLIP (June 23, 2022)
  • K211148 — CORE-Trocar (June 21, 2022)

Other clearances for product code OTJ

  • K232062 — Uni-port (January 16, 2024)
  • K202688 — AFS Medical Sterile Single-Use Access Port System (October 14, 2021)
  • K160797 — FMX314 Surgical Platform (August 26, 2016)
  • K152598 — Endo Keeper (March 17, 2016)
  • K121309 — ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE (September 6, 2012)
  • K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR (August 3, 2012)
  • K111407 — TRIPORT, TRIPORT+, TRIPORT15, QUADPORT (January 18, 2012)
  • K112196 — OCTOTMPORT (September 14, 2011)
  • K110004 — ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE (January 26, 2011)
  • K101794 — ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT (November 29, 2010)

FDA data resources