Aragon Surgical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Aragon Surgical, Inc.” (first 2007, latest 2011), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 112 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| HIF | Insufflator, Laparoscopic | 2 | 2 |
Review panels
Most recent Aragon Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110824 | ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT | GEI | 2011-07-11 | 110 |
| K093075 | ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT | GEI | 2010-01-21 | 113 |
| K090306 | ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT | GEI | 2009-06-18 | 132 |
| K081312 | ARAGON ONESHOT SYSTEM | GEI | 2008-10-31 | 175 |
| K073452 | MODIFICATION TO: ARAGON SURGICAL LAPCAP | HIF | 2008-01-11 | 32 |
| K070651 | ARAGON SURGICAL LAPCAP | HIF | 2007-05-30 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named Aragon Surgical, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Aragon Surgical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Aragon Surgical, Inc.” (first 2007, latest 2011), across 2 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 Aragon Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aragon Surgical, Inc. is 112 days.
Which FDA product codes appear under Aragon Surgical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); HIF (Insufflator, Laparoscopic, 2).
Next steps
- See all 6 Aragon Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Aragon Surgical, Inc.'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.