Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
248 daysmedian FDA review time
334 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240376 | Electroporation System (N3000) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2024-10-04 | 240 | 0 |
| K221995 | Gas Insufflator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2023-03-28 | 265 | 0 |
| K212614 | Ultrasonic Scalpel System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2022-07-18 | 334 | 0 |
| K210488 | Ultrasonic Surgical & Electrosurgical Generator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2021-10-25 | 248 | 0 |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2021-10-13 | 267 | 0 |
| K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019-07-08 | 236 | 0 |
| K190052 | Radio Frequency Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019-06-25 | 165 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda