510(k) K843941
K843941 is an FDA 510(k) premarket notification submitted by Gyneco, Inc. for the device "ENDOCYTE". The FDA issued a decision of Substantially Equivalent on February 25, 1985. The device falls under product code HFE (Brush, Endometrial), a Class II device regulated under 21 CFR 884.1100. Gyneco, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1985
- Date Received
- October 9, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brush, Endometrial
- Device Class
- Class II
- Regulation Number
- 884.1100
- Review Panel
- OB
- Submission Type