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510(k) K121309

ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE by Advanced Surgical Concepts — Product Code OTJ

K121309 is an FDA 510(k) premarket notification submitted by Advanced Surgical Concepts for the device "ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE". The FDA issued a decision of Substantially Equivalent on September 6, 2012. The device falls under product code OTJ (Laparoscopic Single Port Access Device), a Class II device regulated under 21 CFR 876.1500. Advanced Surgical Concepts has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2012
Date Received
May 1, 2012
Clearance Type
Special
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 Advanced Surgical Concepts

  • K232701 — Guardenia (GAR-1) (September 29, 2023)
  • K211234 — RedEx (September 17, 2021)
  • K192898 — PneumoLiner (February 25, 2020)
  • DEN170075 — ContainOR (December 19, 2017)
  • DEN150028 — PneumoLiner (April 7, 2016)
  • K111407 — TRIPORT, TRIPORT+, TRIPORT15, QUADPORT (January 18, 2012)
  • 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)
  • K073719 — ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE (January 29, 2008)
  • K073170 — R-PORT II LAPAROSCOPIC ACCESS DEVICE (December 3, 2007)

Other clearances for product code OTJ

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