Rebotix: FDA clearances and approvals
Rebotix has 5 FDA 510(k) clearances (first 2024, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time: 188 days. Since 2017 its median was 188 days, against 188 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 133 |
| 2025 | 4 | 188 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Rebotix's cleared 510(k)s took a median 188 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QSM | System, Surgical, Computer Controlled Instrument, Remanufactured | 5 | 5 |
Review panels
Most recent Rebotix 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250417 | Remanufactured EndoWrist Cobra Grasper (420190) | QSM | 2025-08-20 | 188 |
| K250539 | Remanufactured EndoWrist Tenaculum Forceps (420207) | QSM | 2025-08-19 | 176 |
| K250399 | Remanufactured EndoWrist Cadiere Forceps (420049) | QSM | 2025-08-19 | 188 |
| K250387 | Remanufactured EndoWrist Long Tip Forceps (420048) | QSM | 2025-08-19 | 189 |
| K241872 | Remanufactured EndoWrist ProGrasp Forceps (420093) | QSM | 2024-11-07 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Rebotix.
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 Rebotix have?
Rebotix has 5 FDA 510(k) clearances (first 2024, latest 2025), across 1 product code in 1 review panel.
How long does FDA take to clear Rebotix's 510(k)s?
The median time from FDA receipt to decision across Rebotix's cleared 510(k)s is 188 days. Since 2017: 188 days, versus 188 days for all cleared 510(k)s in the same product codes.
What devices does Rebotix make?
Its most frequent FDA product codes are QSM (System, Surgical, Computer Controlled Instrument, Remanufactured, 5).
Has Rebotix had device recalls?
openFDA lists no recalls under a recalling firm name matching Rebotix. Related entities may recall under other names.
Next steps
- See all 5 Rebotix clearances with predicates and recalls
- Run predicate analysis for product code QSM, Rebotix'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.