Distalmotion SA: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Distalmotion SA” (first 2025, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 104 days. Since 2017 the median was 104 days, against 104 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2025 | 2 | 134 |
| 2026 | 2 | 104 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Distalmotion SA took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SDD | Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | 5 | 4 |
Review panels
Most recent Distalmotion SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261398 | Dexter L6 System | SDD | 2026-08-11 | 104 |
| K260653 | Dexter L6 System | SDD | 2026-06-11 | 104 |
| K251197 | Dexter L6 System | SDD | 2025-09-30 | 166 |
| K250435 | Dexter L6 System | SDD | 2025-05-27 | 102 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230084 | De Novo | Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | 2024-10-25 |
Recalls
openFDA lists no recalls under a recalling firm named Distalmotion SA.
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 Distalmotion SA is the lead sponsor of 6 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07181876: Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System (Recruiting, started 2025-11-26)
- NCT07123051: Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System (Recruiting, started 2025-08-05)
- NCT07071740: Robotic Minimally Invasive Ventral Hernia Repair With DEXTER (Completed, started 2025-06-11)
- NCT07031050: Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance (Completed, started 2025-05-19)
- NCT05873582: Robotic Minimally Invasive Inguinal Hernia Repair With Dexter (Completed, started 2023-06-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Distalmotion SA?
FDA lists 4 510(k) clearances under the applicant name “Distalmotion SA” (first 2025, latest 2026), 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 Distalmotion SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Distalmotion SA is 104 days. Since 2017: 104 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Distalmotion SA?
The most frequent FDA product codes under this applicant name are SDD (Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field, 5).
Next steps
- See all 4 Distalmotion SA clearances with predicates and recalls
- Run predicate analysis for product code SDD, Distalmotion SA'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.