Ultrasonic Scalpel System— 510(k) K212614

Name: FDA 510(k) clearance K212614
Creator: U.S. Food and Drug Administration
Published: 2022-07-18

Substantially Equivalent

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

FDA 510(k) clearance K212614 for Ultrasonic Scalpel System, Substantially Equivalent on 2022-07-18. Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. Device class: Unclassified.

Clearance details

Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2021-08-18
Decision date: 2022-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cixi, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFL

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K261448 — neXus Ultrasonic Surgical Aspirator System2026-07-30
K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System2025-10-08
K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more2025-06-18
K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)2025-03-24
K241700 — Tenex 2nd Generation System2024-11-18

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K221995 — Gas Insufflator2023-03-28
K210488 — Ultrasonic Surgical & Electrosurgical Generator2021-10-25
K210116 — Video Endoscopy System, 3D Video Endoscopy System2021-10-13
K183153 — Microwave Ablation System2019-07-08

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.