Protégé EverFlex Self-expanding Peripheral Stent System (K262913): 510(k) cleared for Medtronic, Inc.
Protégé EverFlex Self-expanding Peripheral Stent System (K262913): 510(k) cleared for Medtronic, Inc. (Minnesota): 510(k) cleared for Medtronic, Inc. Its amount of 29 is below the median of 138 (7th percentile). Dated 48 days ago, it serves as a historical benchmark. Score 35/100. 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: 29 · 7th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related MN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262913 |
| Device | Protégé EverFlex Self-expanding Peripheral Stent System |
| Applicant | Medtronic, Inc. |
| Specialty / panel | Gastroenterology, Urology |
| Product code | FGE |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-08-19 |
| Decision date | 2026-09-17 |
| Review time (days) | 29 |
| Third-party review | No |
| Applicant location | Plymouth, MN, US |
| amount percentile | 7th of 414 (median 138, 0.2x median) |
| Peer records CSV (12 MN records) | 🔒 Click to unlock → |
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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: 2026-09-17
- 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: Protégé EverFlex Self-expanding Peripheral Stent System (K262913): 510(k) cleared for Medtronic, Inc. and 12 Minnesota peers
- Minnesota FDAPulse records like this one: 12
- Protégé EverFlex Self-expanding Peripheral Stent System (K262913): 510(k) cleared for Medtronic, Inc.'s amount: 7th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Minnesota peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
35 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 29-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
What is the FDAPulse record for Protégé EverFlex Self-expanding Peripheral Stent System (K262913): 510(k) cleared for Medtronic, Inc. in Minnesota?
Protégé EverFlex Self-expanding Peripheral Stent System (K262913) by Medtronic, Inc. was cleared on 2026-09-17 after 29 days of review.
How does Protégé EverFlex Self-expanding Peripheral Stent System (K262913): 510(k) cleared for Medtronic, Inc. compare to other Minnesota FDAPulse records?
Its amount of 29 is below the median (7th percentile); smaller records often move faster and face less competition. It is 48 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 35/100 is modest; treat it as background rather than a priority.
Protégé EverFlex Self-expanding Peripheral Stent System (K262913) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Protégé EverFlex Self-expanding Peripheral Stent System (K262913) | MN | 2026-09-17 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Drainage Catheter (K254179) | CN | 2026-09-18 |
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) | DE | 2026-09-14 |
Related records
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- Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.
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