7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC
7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC (California): 510(k) cleared for 7D Surgical ULC. Its amount of 255 is above the median of 138 (81st percentile). Dated 16 days ago, it is in the active follow-up window. Score 61/100. 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: 255 · 81th percentile of 414 FDAPulse records · 1.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260403 |
| Device | 7D Surgical System (10-0001) |
| Applicant | 7D Surgical ULC |
| Specialty / panel | Neurology |
| Product code | OLO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-06 |
| Decision date | 2026-10-19 |
| Review time (days) | 255 |
| Third-party review | No |
| Applicant location | Toronto, CA |
| amount percentile | 81th of 414 (median 138, 1.8x median) |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-19
- 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: 7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC and 76 California peers
- California FDAPulse records like this one: 76
- 7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC's amount: 81st percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 255-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 16 days ago.
What is the FDAPulse record for 7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC in California?
7D Surgical System (10-0001) (K260403) by 7D Surgical ULC was cleared on 2026-10-19 after 255 days of review.
How does 7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC compare to other California FDAPulse records?
Its amount of 255 sits in the upper half (81th percentile) of 414 records; the median is 138. It is 16 days old, still within a typical 45-day follow-up window.
7D Surgical System (10-0001) (K260403) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 |
| Neurora (K260064) | NH | 2026-10-02 |
| Ventricular Catheters, Thomale Catheter (K260044) | PA | 2026-10-02 |
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