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510(k) K202688

AFS Medical Sterile Single-Use Access Port System by Afs Medical Co. , Ltd. — Product Code OTJ

K202688 is an FDA 510(k) premarket notification submitted by Afs Medical Co. , Ltd. for the device "AFS Medical Sterile Single-Use Access Port System". The FDA issued a decision of Substantially Equivalent on October 14, 2021. The device falls under product code OTJ (Laparoscopic Single Port Access Device), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2021
Date Received
September 15, 2020
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 for product code OTJ

  • K232062 — Uni-port (January 16, 2024)
  • K220081 — CORE-SPORT (September 28, 2022)
  • 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