Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider— 510(k) K172856
Substantially EquivalentStryker Sustainability Solutions
FDA 510(k) clearance K172856 for Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider, Substantially Equivalent on 2017-11-16. Applicant: Stryker Sustainability Solutions. Device class: 2.
Clearance details
- Applicant
- Stryker Sustainability Solutions
- Product code
- 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
Recent devices under product code GEI
view allMore 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
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.