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510(k) K101794

ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA by Advanced Surgical Concepts — Product Code OTJ

K101794 is an FDA 510(k) premarket notification submitted by Advanced Surgical Concepts for the device "ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA". The FDA issued a decision of Substantially Equivalent on November 29, 2010. 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
November 29, 2010
Date Received
June 28, 2010
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)
  • K121309 — ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE (September 6, 2012)
  • K111407 — TRIPORT, TRIPORT+, TRIPORT15, QUADPORT (January 18, 2012)
  • K110004 — ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE (January 26, 2011)
  • 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)
  • 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)

FDA data resources