510(k) K834402
K834402 is an FDA 510(k) premarket notification submitted by Hobbs Medical, Inc. for the device "GASTROINTESTINAL SHEATH BRUSH". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Hobbs Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1984
- Date Received
- December 14, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Cytology Brush
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To collect cells for cytological evaluation.