510(k) K060320
K060320 is an FDA 510(k) premarket notification submitted by Femspec LLC for the device "FEMECC ENDOCERVICAL CURETTE". The FDA issued a decision of Substantially Equivalent on July 28, 2006. The device falls under product code PCF (Sampler, Endocervical), a Class II device regulated under 21 CFR 884.1050. Femspec LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2006
- Date Received
- February 8, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sampler, Endocervical
- Device Class
- Class II
- Regulation Number
- 884.1050
- Review Panel
- OB
- Submission Type
Obtains tissue samples from the endocervical canal for histological analysis.