Advanced Surgical Concepts: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Advanced Surgical Concepts” (first 2007, latest 2023), plus 2 De Novo decisions, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 132 days. Since 2017 the median was 137 days, against 96 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 186 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 137 |
| 2021 | 1 | 147 |
| 2022 | 0 | — |
| 2023 | 1 | 24 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Advanced Surgical Concepts took a median 137 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| OTJ | Laparoscopic Single Port Access Device | 4 | 4 |
| PMU | Containment System, Laparoscopic Power Morcellation, With Instrument Port | 2 | 1 |
| PZQ | General Laparoscopic Power Morcellation Containment System | 1 | 0 |
Review panels
Most recent Advanced Surgical Concepts 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232701 | Guardenia (GAR-1) | GCJ | 2023-09-29 | 24 |
| K211234 | RedEx | GCJ | 2021-09-17 | 147 |
| K192898 | PneumoLiner | PMU | 2020-02-25 | 137 |
| K121309 | ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE | OTJ | 2012-09-06 | 128 |
| K111407 | TRIPORT, TRIPORT+, TRIPORT15, QUADPORT | OTJ | 2012-01-18 | 244 |
| K110004 | ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE | OTJ | 2011-01-26 | 23 |
| K101794 | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA | OTJ | 2010-11-29 | 154 |
| K073719 | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE | GCJ | 2008-01-29 | 29 |
| K073170 | R-PORT II LAPAROSCOPIC ACCESS DEVICE | GCJ | 2007-12-03 | 24 |
| K070158 | R-PORT LAPAROSCOPIC ACCESS DEVICE | GCJ | 2007-08-23 | 218 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170075 | De Novo | General Laparoscopic Power Morcellation Containment System | 2017-12-19 |
| DEN150028 | De Novo | Containment System, Laparoscopic Power Morcellation, With Instrument Port | 2016-04-07 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Surgical Concepts.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Surgical Concepts?
FDA lists 10 510(k) clearances under the applicant name “Advanced Surgical Concepts” (first 2007, latest 2023), plus 2 De Novo decisions, across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Advanced Surgical Concepts?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Surgical Concepts is 132 days. Since 2017: 137 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Advanced Surgical Concepts?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 5); OTJ (Laparoscopic Single Port Access Device, 4); PMU (Containment System, Laparoscopic Power Morcellation, With Instrument Port, 2).
Next steps
- See all 10 Advanced Surgical Concepts clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Advanced Surgical Concepts's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.