510(k) K041237
K041237 is an FDA 510(k) premarket notification submitted by Gynetics Medical Products NV for the device "ECHOSAMPLER". The FDA issued a decision of Substantially Equivalent on Sep 8, 2004. The device falls under product code HFF (Aspirator, Endometrial), a Class II device regulated under 21 CFR 884.1060. Gynetics Medical Products NV has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 8, 2004
- Date Received
- May 11, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Aspirator, Endometrial
- Device Class
- Class II
- Regulation Number
- 884.1060
- Review Panel
- OB
- Submission Type
- 510(k)