510(k) K880648
K880648 is an FDA 510(k) premarket notification submitted by Superior Healthcare Group, Inc. for the device "ENDOSCOPIC ELASTIC BAND LIGATOR". The FDA issued a decision of Substantially Equivalent on April 6, 1988. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. Superior Healthcare Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 1988
- Date Received
- February 17, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ligator, Hemorrhoidal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type