510(k) K882048
K882048 is an FDA 510(k) premarket notification submitted by Xylog Corp. for the device "MEDITRON ENDOLAV MODEL EL-100". The FDA issued a decision of Substantially Equivalent on October 31, 1988. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Xylog Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1988
- Date Received
- May 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type