# K012435: Entry Site Alignment System Model # CX9626

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Oct 2, 2001 after 63 days
- Product code: NGY (Cannula, Trocar, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alcon/Grieshaber Trocar Cannula Set: named in the summary without a submission number

## Indications for use
The ESA is a hand-held surgical instrument intended for use as a trocar/cannula for establishing an entry site conduit for passing ophthalmic instruments/accessories used to perform posterior ophthalmic surgical procedures.

Source page: https://510kreport.com/device/K012435
Methodology: https://510kreport.com/methodology