# Advanced Surgical Concepts

- Location (FDA's records): Bray, IE
- FDA decisions: 12 (2007–2023): 10 510(k) clearances and 2 De Novo grants
- Names in FDA's records: Advanced Surgical Concepts (9); Advanced Surgical Concepts, Ltd. (3)
- Product codes: GCJ (5), OTJ (4), PMU (2), PZQ (1)
- Predicates its devices cite: 23 (11 its own); citations of its devices by later devices: 19 (11 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ethicon Endo-Surgery, Inc.: 4 (https://510kreport.com/company/ethicon-endo-surgery)
- Taut, Inc.: 3 (https://510kreport.com/company/taut)
- Advanced Surgical Concepts (Asc): 3 (https://510kreport.com/company/advanced-surgical-concepts-asc)
- Applied Medical Resources: 2 (https://510kreport.com/company/applied-medical-resources)

## Firms that cite its devices most
- Covidien Lp, Formerly Registered AS United States: 1 (https://510kreport.com/company/covidien-lp-formerly-registered-as-united-states)
- Nelis: 1 (https://510kreport.com/company/nelis)
- Richard Wolf Medical Instruments Corp.: 1 (https://510kreport.com/company/richard-wolf-medical-instruments)
- Hangzhou Kangji Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-kangji-medical-instrument)
- Innovia, LLC: 1 (https://510kreport.com/company/innovia)
- Ark Surgical, Ltd.: 1 (https://510kreport.com/company/ark-surgical)
- Agency For Medical Innovations GmbH: 1 (https://510kreport.com/company/agency-for-medical-innovations)
- Dalim Surgnet Corporation: 1 (https://510kreport.com/company/dalim-surgnet)

## Its most-cited devices
- K073719: Asc Triport Laparoscopic Access Device (2008), cited by 5
- K070158: R-Port Laparoscopic Access Device (2007), cited by 3
- K073170: R-Port II Laparoscopic Access Device (2007), cited by 3
- K110004: Asc Triport+ Laparoscopic Access Device (2011), cited by 3
- K192898: PneumoLiner (2020), cited by 2
- K211234: RedEx (2021), cited by 1

## Recent decisions
- K232701: Guardenia (GAR-1) (Sep 29, 2023)
- K211234: RedEx (Sep 17, 2021)
- K192898: PneumoLiner (Feb 25, 2020)
- DEN170075: ContainOR (Dec 19, 2017)
- DEN150028: PneumoLiner (Apr 7, 2016)
- K121309: Asc Quadport + Laparoscopic Access Device (Sep 6, 2012)
- K111407: Triport, Triport+, TRIPORT15, Quadport (Jan 18, 2012)
- K110004: Asc Triport+ Laparoscopic Access Device (Jan 26, 2011)

Source page: https://510kreport.com/company/advanced-surgical-concepts