Prescient Surgical, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Prescient Surgical, Inc.” (first 2017, latest 2017), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 103 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 |
|---|---|---|
| 2017 | 1 | 103 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Prescient Surgical, Inc. took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQI | Wound Retraction And Protection System | 2 | 1 |
Review panels
Most recent Prescient Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172132 | CleanCision Wound Retraction and Protection System | PQI | 2017-10-25 | 103 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150038 | De Novo | Wound Retraction And Protection System | 2016-12-16 |
Recalls
openFDA lists no recalls under a recalling firm named Prescient 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.
Device clinical trials
An industry sponsor named Prescient Surgical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02413879: Cleancision IntRaoperative Contamination prEvention Study (Completed, started 2015-03)
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.
- Prescient Imaging, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Prescient Surgical, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Prescient Surgical, Inc.” (first 2017, latest 2017), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Prescient Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prescient Surgical, Inc. is 103 days.
Which FDA product codes appear under Prescient Surgical, Inc.?
The most frequent FDA product codes under this applicant name are PQI (Wound Retraction And Protection System, 2).
Next steps
- See all 1 Prescient Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PQI, Prescient 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.