510(k) K970083
K970083 is an FDA 510(k) premarket notification submitted by Portlyn Corp. for the device "DYNABITE HOT GI BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on June 17, 1997. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Portlyn Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1997
- Date Received
- January 9, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Biopsy, Electric
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type