Cleared Traditional

K250688 - Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US) (FDA 510(k) Clearance)

Also includes:
Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US) Endovenous Radiofrequency Generator (ERA-G5-US)

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

K250688 · Acotec Scientific Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
215d
Days
Class 2
Risk

K250688 is an FDA 510(k) clearance for the Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Acotec Scientific Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on October 7, 2025 after a review of 215 days - an extended review cycle.

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 Acotec Scientific Co., Ltd. devices

Submission Details

510(k) Number K250688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2025
Decision Date October 07, 2025
Days to Decision 215 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 114d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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

Fabrica Consulting, LLC
Sara Toyloy

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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2294
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K250688.
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