510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843646Substantially Equivalent

Steinway Micro-Kerato-Trephine

Steinway Instrument Co., Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843646 is the FDA 510(k) clearance record for STEINWAY MICRO-KERATO-TREPHINE, a class I device, cleared for Steinway Instrument Co., Inc. on under FDA product code HRH (Trephine, Manual, Ophthalmic). FDA records list one 510(k) clearance for Steinway Instrument Co., Inc. As of , FDA records show no recalls naming K843646.

Clearance record

Decision date
Received
(108 days to decision)
Product code
HRH Trephine, Manual, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Steinway Instrument Co., Inc. 5466 Complex St. #205, San Diego CA
Third party review
No

Clearances, product code HRH

Trailing 12 months

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

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