510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930113Substantially Equivalent

Kirwan Irrigation/aspiration Handpiece

Kirwan Surgical Products, LLC, Rockland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930113 is the FDA 510(k) clearance record for KIRWAN IRRIGATION/ASPIRATION HANDPIECE, a class I device, cleared for Kirwan Surgical Products, Inc. on under FDA product code HMX (Cannula, Ophthalmic). FDA records list 19 510(k) clearances for Kirwan Surgical Products, Inc., from to . As of , FDA records show no recalls naming K930113.

Clearance record

Decision date
Received
(402 days to decision)
Product code
HMX Cannula, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Kirwan Surgical Products, Inc. 83 E. Water St., Rockland MA
510(k) summary
Statement
Third party review
No

Clearances, product code HMX

Trailing 12 months

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

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