Surgiquest, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Surgiquest, Inc.” (first 2007, latest 2015), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 76 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 | 1 | 61 |
| 2013 | 1 | 38 |
| 2014 | 0 | — |
| 2015 | 1 | 112 |
| 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 6 | 6 |
| HIF | Insufflator, Laparoscopic | 3 | 3 |
Review panels
Most recent Surgiquest, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143404 | SurgiQuest AirSeal iFS System | HIF | 2015-03-20 | 112 |
| K132169 | SURGIQUEST AIRSEAL IFS | GCJ | 2013-08-22 | 38 |
| K121336 | MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 | HIF | 2012-07-03 | 61 |
| K103692 | SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 | HIF | 2011-05-25 | 159 |
| K100180 | SURGIQUEST ANCHORPORT SIL KIT | GCJ | 2010-05-05 | 104 |
| K092504 | SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM | GCJ | 2009-11-05 | 83 |
| K083211 | AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM | GCJ | 2008-12-15 | 45 |
| K071571 | SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM | GCJ | 2007-07-30 | 52 |
| K063859 | SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA | GCJ | 2007-03-14 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named Surgiquest, 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 Surgiquest, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Surgiquest, Inc.” (first 2007, latest 2015), 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 Surgiquest, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgiquest, Inc. is 76 days.
Which FDA product codes appear under Surgiquest, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 6); HIF (Insufflator, Laparoscopic, 3).
Next steps
- See all 9 Surgiquest, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Surgiquest, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.