510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012435Substantially Equivalent

Entry Site Alignment System Model # Cx9626

Bausch & Lomb Incorporated, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012435 is the FDA 510(k) clearance record for ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626, a class I device, cleared for Bausch & Lomb, Inc. on under FDA product code NGY (Cannula, Trocar, Ophthalmic). FDA's definition for product code NGY reads: "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...". FDA records list 131 510(k) clearances for Bausch & Lomb Incorporated, from to . As of , FDA records show no recalls naming K012435.

Clearance record

Decision date
Received
(63 days to decision)
Product code
NGY Cannula, Trocar, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Bausch & Lomb, Inc. 3365 Tree Ct. Industrial Blvd., St. Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code NGY

Trailing 12 months

FDA records hold no clearances under product code NGY in the trailing twelve months.

FDA records show no clearances under product code NGY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NGY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260