Identifiers
- 510(k) Number
- K041237 FDA 510(k)
- FDA Product Code
- HFF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1060 FDA 510(k)
- Regulation Number
- 884.1060 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Echosampler is an endometrial aspirator classified as a Class II obstetrics/gynecology device. It is designed to obtain endometrial tissue samples for diagnostic purposes in women undergoing gynecologic evaluation.
The device was cleared by the FDA through a traditional 510(k) submission (K041237) as substantially equivalent to a predicate device. It is marketed by Gynetics Medical Products NV and is regulated under 21 CFR 884.1060 (product code HFF).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gynetics Medical Products NV #5164 Echosampler Echosampler, ECHOSAMPLER (K041237) — FDA 510(k) | Innolitics, Endometrial curette Medical Device Identification, PDF ENGLISH ENGLISH #5164 ECHOSAMPLER - gynetics.be, ECHOSAMPLER 510 (k) K041237 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041237 | Class II | Active |
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Manufacturer
- Manufacturer
- Gynetics Medical Products NV
Sources (1)
- FDA 510(k) K041237 24 fields · synced Sep 24, 2026