Co-Ablation System with Sterile Co-Ablation Probe

K243042

Hygea Medical Technology Co., Ltd. · cleared 2025-01-29 · product code GEH · General and Plastic Surgery

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.7)
“The Co-Ablation System with Sterile Co-Ablation Probe is a device designed to freeze/ablate tissue. It utilizes phase change effect to generate extremely low temperature and high temperature to destroy lesion tissues with a combined working mode, to achieve better clinical efficacy, safety and efficiency. The Co-Ablation System is a mobile medical equipment.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.19)
“The software development is in accordance with IEC 62304, FDA guidance for the content of premarket submissions for software contained in Medical devices and FDA guidance for Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. And the software verification/validation met the acceptance criteria.”

Validation studies (2)

Bench

sample size not stated

endpoints: meeting basic safety and essential performance requirements; meeting EMC requirements; evaluating user interface usability; software verification/validation met acceptance criteria; sterilization validation; biocompatibility testing; shelf life and packaging validity; correlation of co-ablation volume with treatment parameters; ice ball verification; temperature probe measurement accuracy

standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, IEC 62304, ISO 11135, ISO 11737-1, ISO 11737-2, ISO11607-1, ISO 11607-2, ISO 10993 related standards

Bench

sample size not stated

endpoints: efficacy; safety; usability; stable vital signs; no device abnormalities

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

11
recalls in product code, 24mo
225
MAUDE reports in code, 12mo
+41%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the General and Plastic Surgery panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243042