Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider— 510(k) K180451
Substantially EquivalentStryker Sustainability Solutions
FDA 510(k) clearance K180451 for Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider, Substantially Equivalent on 2018-04-20. Applicant: Stryker Sustainability Solutions. Device class: 2.
Clearance details
- Applicant
- Stryker Sustainability Solutions
- Product code
- Code NUJ
- 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
Recent devices under product code NUJ
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- K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- K211203 — Green OR Reprocessed Aquamantys Bipolar Sealer
- K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
More clearances from Stryker Sustainability Solutions
view all- K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
- K250898 — Reprocessed HARMONIC 700 Shears (3 models)
- K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) +3 more
- K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120) +1 more
- K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120) +1 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.