Renovo, Inc.: FDA clearances and approvals
Renovo, Inc. has 6 FDA 510(k) clearances (first 2017, latest 2018), across 3 product codes in 3 review panels. Median 510(k) review time: 88 days. Since 2017 its median was 88 days, against 90 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Renovo, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 3 | 86 |
| 2018 | 3 | 102 |
| 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, Renovo, Inc.'s cleared 510(k)s took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 3 | 3 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
Review panels
Most recent Renovo, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173740 | Reprocessed DePuy Mitek Ablation Wand | NUJ | 2018-03-19 | 102 |
| K173741 | Reprocessed ArthoCare Ablation Wand | NUJ | 2018-03-05 | 88 |
| K172647 | Reprocessed ArthroCare ENT Coblator | NUJ | 2018-02-21 | 173 |
| K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves | NLM | 2017-10-06 | 87 |
| K172093 | Reprocessed Covidien Trocar | NLM | 2017-10-05 | 86 |
| K172092 | Reprocessed Shavers/Burs | HRX | 2017-10-04 | 85 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-01-19.
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 Renovo, Inc. have?
Renovo, Inc. has 6 FDA 510(k) clearances (first 2017, latest 2018), across 3 product codes in 3 review panels.
How long does FDA take to clear Renovo, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Renovo, Inc.'s cleared 510(k)s is 88 days. Since 2017: 88 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Renovo, Inc. make?
Its most frequent FDA product codes are NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, 3); NLM (Laparoscope, General & Plastic Surgery, Reprocessed, 2); HRX (Arthroscope, 1).
Has Renovo, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Renovo, Inc; the most recent began 2021-01-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Renovo, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NUJ, Renovo, Inc.'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.