510(k) K012435
K012435 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626". The FDA issued a decision of Substantially Equivalent on October 2, 2001. The device falls under product code NGY (Cannula, Trocar, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2001
- Date Received
- July 31, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Trocar, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type
The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.