General Project S.R.L.: FDA clearances and approvals
General Project S.R.L. has 5 FDA 510(k) clearances (first 2005, latest 2016), across 2 product codes in 2 review panels. Median 510(k) review time: 120 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 76 |
| 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
Review panels
Most recent General Project S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161502 | MC1 Plus | IMI | 2016-08-16 | 76 |
| K091615 | MED CONTOUR | IMI | 2010-05-06 | 337 |
| K062312 | AXIOM PULSED LIGHT SYSTEM | GEX | 2006-10-16 | 69 |
| K053041 | MED SCULPT | IMI | 2006-08-02 | 279 |
| K051508 | MED FLASH II INTENSE PULSED LIGHT SYSTEM. | GEX | 2005-10-05 | 120 |
Recalls
openFDA lists no recalls under a recalling firm named General Project S.R.L..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does General Project S.R.L. have?
General Project S.R.L. has 5 FDA 510(k) clearances (first 2005, latest 2016), across 2 product codes in 2 review panels.
How long does FDA take to clear General Project S.R.L.'s 510(k)s?
The median time from FDA receipt to decision across General Project S.R.L.'s cleared 510(k)s is 120 days.
What devices does General Project S.R.L. make?
Its most frequent FDA product codes are IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 3); GEX (Powered Laser Surgical Instrument, 2).
Has General Project S.R.L. had device recalls?
openFDA lists no recalls under a recalling firm name matching General Project S.R.L. Related entities may recall under other names.
Next steps
- See all 5 General Project S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code IMI, General Project S.R.L.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.