510(k) K964561
K964561 is an FDA 510(k) premarket notification submitted by Bioenterics Corp. for the device "ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA". The FDA issued a decision of Substantially Equivalent on February 11, 1997. The device falls under product code FDG (Retractor, Fiberoptic), a Class I device regulated under 21 CFR 876.4530. Bioenterics Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 1997
- Date Received
- November 13, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor, Fiberoptic
- Device Class
- Class I
- Regulation Number
- 876.4530
- Review Panel
- GU
- Submission Type