510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961524Substantially Equivalent

Sterilab Cannulas, Sterilab Cystotmes, Sterilab Needles and Sterilab Lens Manipulators

Sterilab, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961524 is the FDA 510(k) clearance record for STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS, a class I device, cleared for Sterilab, Inc. on under FDA product code HNY (Cystotome). FDA records list one 510(k) clearance for Sterilab, Inc. As of , FDA records show no recalls naming K961524.

Clearance record

Decision date
Received
(24 days to decision)
Product code
HNY Cystotome
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Sterilab, Inc. 6068 Corte Del Cedro, Carlsbad CA
510(k) summary
Statement
Third party review
No

Clearances, product code HNY

Trailing 12 months

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

FDA records show no clearances under product code HNY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HNY, 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