OMS INFUSION CANNULA ASSEMBLE— 510(k) K813481

Clearance details

Applicant

Optical Micro Systems, Inc.

Product code

Code HMX

Device class

Class 1

Regulation

21 CFR 886.4350

Advisory panel

Ophthalmic

Date received

1981-12-01

Decision date

1982-01-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K010305 — WEISS RETINAL CANNULA2001-05-02
• K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES2000-05-09
• K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)1997-05-20
• K943932 — STERISEAL OPHTHALMIC CANNULA1995-01-18
• K942403 — INFUSION CANNULA1994-08-17

• K950218 — OMS SLIMLINE PHACO HANDPIECE1995-07-17
• K946054 — DIPLOMAX1995-07-11
• K935223 — OPHTHALMIC SURGICAL SYSTEM1994-03-14
• K935226 — I/V POLE1994-02-16
• K935003 — ELECTRIC I/V POLE OR EIVP21994-01-25

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →