Advanced Surgical Concepts

Bray, IE

Advanced Surgical Concepts appears in FDA device records in Bray, IE. FDA records list 12 510(k) clearances between 2007-08-23 and 2023-09-29, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 12
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 12 510(k) clearances for Advanced Surgical Concepts between 2007 and 2023. The busiest year on record is 2007, with 2. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for Advanced Surgical Concepts, by decision year
Year	Clearances
2007	2
2008	1
2010	1
2011	1
2012	2
2016	1
2017	1
2020	1
2021	1
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K232701	Guardenia (GAR-1)	GCJ	Substantially Equivalent	2023-09-29
K211234	RedEx	GCJ	Substantially Equivalent	2021-09-17
K192898	PneumoLiner	PMU	Substantially Equivalent	2020-02-25
DEN170075	ContainOR	PZQ	Unknown	2017-12-19
DEN150028	PneumoLiner	PMU	Unknown	2016-04-07
K121309	ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE	OTJ	Substantially Equivalent	2012-09-06
K111407	TRIPORT, TRIPORT+, TRIPORT15, QUADPORT	OTJ	Substantially Equivalent	2012-01-18
K110004	ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE	OTJ	Substantially Equivalent	2011-01-26
K101794	ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA	OTJ	Substantially Equivalent	2010-11-29
K073719	ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE	GCJ	Substantially Equivalent	2008-01-29
K073170	R-PORT II LAPAROSCOPIC ACCESS DEVICE	GCJ	Substantially Equivalent	2007-12-03
K070158	R-PORT LAPAROSCOPIC ACCESS DEVICE	GCJ	Substantially Equivalent	2007-08-23

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain