Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited
Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited: 510(k) cleared for Cmr Surgical Limited. Its amount of 188 is above the median of 138 (67th percentile). Dated 14 days ago, it is in the active follow-up window. Score 54/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 188 · 67th percentile of 414 FDAPulse records · 1.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 7 related GB FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261252 |
| Device | Versius Surgical System (Versius Plus) |
| Applicant | Cmr Surgical Limited |
| Specialty / panel | General, Plastic Surgery |
| Product code | SCV |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-16 |
| Decision date | 2026-10-21 |
| Review time (days) | 188 |
| Third-party review | No |
| Applicant location | Cambridge, GB |
| amount percentile | 67th of 414 (median 138, 1.4x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited and 8 GB peers
- GB FDAPulse records like this one: 8
- Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited's amount: 67th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every GB peer: $1,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
54 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 188-day review, longer than typical.
- Posted 14 days ago.
What is the FDAPulse record for Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited?
Versius Surgical System (Versius Plus) (K261252) by Cmr Surgical Limited was cleared on 2026-10-21 after 188 days of review.
How does Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited compare to other FDAPulse records?
Its amount of 188 sits in the upper half (67th percentile) of 414 records; the median is 138. It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Versius Surgical System (Versius Plus) (K261252) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Versius Surgical System (Versius Plus) (K261252) | GB | 2026-10-21 |
| TECAR Therapy Device (TC2000, TC2001) (K252288) | CN | 2026-10-13 |
| easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291) | CN | 2026-09-25 |
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: General & Plastic Surgery devices
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