NanoKnife System— 510(k) K183385
Substantially EquivalentAngiodynamics
FDA 510(k) clearance K183385 for NanoKnife System, Substantially Equivalent on 2019-06-18. Applicant: Angiodynamics. Device class: 2.
Clearance details
- Applicant
- Angiodynamics
- Product code
- Code OAB
- 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
- Marlborough, MA, US
Recent devices under product code OAB
view all- K253846 — Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02) +2 more
- K253826 — Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
- K253198 — NanoKnife Generator (H78720300351US0)
- K242687 — NanoKnife Generator (H78720300301US0) +3 more
- K240376 — Electroporation System (N3000)
More clearances from Angiodynamics
view allAdverse events under product code OAB
product code OAB- Death
- 5
- Total
- 5
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 →
Recalls naming K183385
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183385.
Data sourced from openFDA. This site is unofficial and independent of the FDA.