REPROCESSED HAND ACTIVATE SEALER/DIVIDER— 510(k) K111600
Substantially EquivalentAscent Healthcare Solutions
FDA 510(k) clearance K111600 for REPROCESSED HAND ACTIVATE SEALER/DIVIDER, Substantially Equivalent on 2011-11-15. Applicant: Ascent Healthcare Solutions. Device class: 2.
Clearance details
- Applicant
- Ascent Healthcare 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
- Phoenix, AZ, US
Recent devices under product code NUJ
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- K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- 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 Ascent Healthcare Solutions
view all- K110189 — REPROCESSED ELECTROSURGICAL INSTRUMENT
- K100909 — REPROCESSED COMPRESSION SLEEVES
- K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
- K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
- K100080 — REPROCESSED TROCARS, MODEL B5LT AND CB5LT
Data sourced from openFDA. This site is unofficial and independent of the FDA.