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510(k) DEN170075

ContainOR by Advanced Surgical Concepts, Ltd. — Product Code PZQ

DEN170075 is an FDA 510(k) premarket notification submitted by Advanced Surgical Concepts, Ltd. for the device "ContainOR". The FDA issued a decision of De Novo Granted on December 19, 2017. The device falls under product code PZQ (General Laparoscopic Power Morcellation Containment System), a Class II device regulated under 21 CFR 878.4825. Advanced Surgical Concepts, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 19, 2017
Date Received
September 29, 2017
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
General Laparoscopic Power Morcellation Containment System
Device Class
Class II
Regulation Number
878.4825
Review Panel
SU
Submission Type

Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures.

Other clearances by Advanced Surgical Concepts, Ltd.

  • K232701 — Guardenia (GAR-1) (September 29, 2023)
  • K211234 — RedEx (September 17, 2021)
  • K192898 — PneumoLiner (February 25, 2020)
  • 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)
  • 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)

FDA data resources