FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NanoKnife System
K Number: K150089
·
Decision Jun 18, 2015
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
13
Applicant Total
87
Review Days
153
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Basic Information
- Device Name
- NanoKnife System
- K Number
- K150089
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AngioDynamics, Inc.
- Date Received
- January 16, 2015
- Decision Date
- June 18, 2015
- Product Code
- OAB
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OAB | Low Energy Direct Current Thermal Ablation System | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAB), ordered by most recent decision date.
Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
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Other Clearances by AngioDynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | Nov 24, 2025 | Substantially Equivalent |
| K253106 | AngioVac Cannula | Oct 24, 2025 | Substantially Equivalent |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | Dec 6, 2024 | Substantially Equivalent |
| K240397 | AlphaVac MMA F1885 System (H787253020) | Apr 1, 2024 | Substantially Equivalent |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | Jul 20, 2023 | Substantially Equivalent |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | Mar 27, 2023 | Substantially Equivalent |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | Mar 7, 2023 | Substantially Equivalent |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | Apr 4, 2022 | Substantially Equivalent |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | Dec 3, 2021 | Substantially Equivalent |
| K212386 | AngioVac F18 85 | Sep 30, 2021 | Substantially Equivalent |