LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070): 510(k) cleared for Covidien, LLC
LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070): 510(k) cleared for Covidien, LLC (Colorado): 510(k) cleared for Covidien, LLC. Its amount of 167 is above the median of 138 (60th percentile). Dated 50 days ago, it serves as a historical benchmark. Score 42/100. 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: 167 · 60th percentile of 414 FDAPulse records · 1.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related CO FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261070 |
| Device | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated |
| Applicant | Covidien, LLC |
| Specialty / panel | General, Plastic Surgery |
| Product code | GEI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-01 |
| Decision date | 2026-09-15 |
| Review time (days) | 167 |
| Third-party review | No |
| Applicant location | Lafayette, CO, US |
| amount percentile | 60th of 414 (median 138, 1.2x 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: 2026-09-15
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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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: LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070): 510(k) cleared for Covidien, LLC and 9 Colorado peers
- Colorado FDAPulse records like this one: 9
- LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070): 510(k) cleared for Covidien, LLC's amount: 60th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Colorado peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 167-day review, longer than typical.
What is the FDAPulse record for LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070): 510(k) cleared for Covidien, LLC in Colorado?
LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070) by Covidien, LLC was cleared on 2026-09-15 after 167 days of review.
How does LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070): 510(k) cleared for Covidien, LLC compare to other Colorado FDAPulse records?
Its amount of 167 sits in the upper half (60th percentile) of 414 records; the median is 138. It is 50 days old; check the official source for later updates before acting.
LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070) | CO | 2026-09-15 |
| 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 |
Related records
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