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Pathway
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Model 6320 · UDI-DI 00852423006202
HIR
Prescription
10
510(k) clearances
2
Adverse events
1
Recalls
27
Facilities
Description
Pathway® 6320 Vaginal/Rectal EMG Sensor
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-07-12 | Ralston Group | The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the de |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.