510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993190Substantially Equivalent

Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)

Surgical Instrument Systems (Sis), Ltd., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993190 is the FDA 510(k) clearance record for ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS), a class I device, cleared for Surgical Instrument Systems (Sis), Ltd. on under FDA product code HNO (Keratome, Ac-Powered). FDA records list one 510(k) clearance for Surgical Instrument Systems (Sis), Ltd. As of , FDA records show no recalls naming K993190.

Clearance record

Decision date
Received
(140 days to decision)
Product code
HNO Keratome, Ac-Powered
Regulation
21 CFR 886.4370
Device class
Class I
Review panel
Ophthalmic
Applicant
Surgical Instrument Systems (Sis), Ltd. 18732 Saginaw, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code HNO

Trailing 12 months

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

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