Medical Device Manufacturer · US , North Attleboro , MA

Advanced Surgical Concepts

9 submissions · 9 cleared · Since 2007
9
Total
9
Cleared
0
Denied

Advanced Surgical Concepts — FDA 510(k) Submissions

Advanced Surgical Concepts has submitted 9 FDA 510(k) premarket notifications since 2007, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Laparoscopic Single Port Access Device, Laparoscope, General & Plastic Surgery, Containment System, Laparoscopic Power Morcellation, With Instrument Port . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
Guardenia (GAR-1)
K232701 · GCJ Laparoscope, General &... · General & Plastic Surgery
Sep 2023 24d
PneumoLiner
K192898 · PMU Containment System,... · Obstetrics & Gynecology
Feb 2020 137d
ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
K121309 · OTJ Laparoscopic Single Port... · General & Plastic Surgery
Sep 2012 128d
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
K111407 · OTJ Laparoscopic Single Port... · General & Plastic Surgery
Jan 2012 244d
ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
K110004 · OTJ Laparoscopic Single Port... · General & Plastic Surgery
Jan 2011 23d
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA
K101794 · OTJ Laparoscopic Single Port... · General & Plastic Surgery
Nov 2010 154d
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE
K073719 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jan 2008 29d
R-PORT II LAPAROSCOPIC ACCESS DEVICE
K073170 · GCJ Laparoscope, General &... · General & Plastic Surgery
Dec 2007 24d
R-PORT LAPAROSCOPIC ACCESS DEVICE
K070158 · GCJ Laparoscope, General &... · General & Plastic Surgery
Aug 2007 218d
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