510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874963Substantially Equivalent

Manual Ophthalmic Surgical Instruments

Solway, Inc., Hollywood FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874963 is the FDA 510(k) clearance record for MANUAL OPHTHALMIC SURGICAL INSTRUMENTS, a class I device, cleared for Solway, Inc. on under FDA product code HNA (Spud, Ophthalmic). FDA records list 13 510(k) clearances for Solway, Inc., from to . As of , FDA records show no recalls naming K874963.

Clearance record

Decision date
Received
(21 days to decision)
Product code
HNA Spud, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Solway, Inc. Post Office Box 7647, Hollywood FL
Third party review
No

Clearances, product code HNA

Trailing 12 months

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

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