Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating— 510(k) K260636
Substantially EquivalentStryker Sustainability Solutions
FDA 510(k) clearance K260636 for Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating, Substantially Equivalent on 2026-06-18. Applicant: Stryker Sustainability Solutions. Device class: 2.
Summary
Stryker Sustainability Solutions' Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The remanufactured status and the absence of nano-coating come from the device name.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Stryker Sustainability Solutions filed from Tempe, Arizona. Review took 112 calendar days (February 26 to June 18, 2026).
Clearance details
- Applicant
- Stryker Sustainability Solutions
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
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view all- K250898 — Reprocessed HARMONIC 700 Shears (3 models)
- K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) +3 more
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Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.