510(k) K931044
K931044 is an FDA 510(k) premarket notification submitted by Gi Supply for the device "OXY-BLOC". The FDA issued a decision of Substantially Equivalent on October 4, 1993. The device falls under product code MNK (Endoscopic Bite Block), a Class I device regulated under 21 CFR 876.1500. Gi Supply has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1993
- Date Received
- March 1, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Bite Block
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.