Cleared Traditional

SurBlate Ablation System (K223272) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223272 · Mima-Pro Scientific, Inc. · General & Plastic Surgery device
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Feb 2023
Decision
127d
Days
Class 2
Risk

K223272 is an FDA 510(k) clearance for the SurBlate Ablation System. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Mima-Pro Scientific, Inc. (Richmond, CA). The FDA issued a Cleared decision on February 28, 2023 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Mima-Pro Scientific, Inc. devices

Submission Details

510(k) Number K223272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2022
Decision Date February 28, 2023
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NEY System, Ablation, Microwave And Accessories

All 36
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K223272.
swiftPro System
K222388 · Emblation , Ltd. · May 2023
Solero Microwave Tissue Ablation (MTA) System and Accessories
K223581 · AngioDynamics, Inc. · Mar 2023
Solero Microwave Tissue Ablation (MTA) System and Accessories
K221883 · AngioDynamics, Inc. · Mar 2023
Creo Electrosurgical System with NP1 Instrument
K221672 · Creo Medical, Ltd. · Feb 2023
NEUWAVE Microwave Ablation System and Accessories
K220472 · Neuwave Medical, Inc. · Aug 2022
Solero Microwave Tissue Ablation (MTA) System and Accessories
K213067 · AngioDynamics, Inc. · Dec 2021

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.