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

Drape, Microscope, Ophthalmic

21 CFR 878.4370 / General, Plastic Surgery
FDA source (opens on fda.gov)

HMW is the FDA product code for Drape, Microscope, Ophthalmic, a class II device type, regulated under 21 CFR 878.4370. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HMW
Device name
Drape, Microscope, Ophthalmic
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code HMW

By decision year
4 clearances under product code HMW with a decision year between 1984 and 1991, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HMW by decision year
YearClearances
19841
19902
19911

Applicants with the most clearances

Product code HMW
Applicants holding the most 510(k) clearances under product code HMW
ApplicantClearances
Invotec International, Inc.1
Lifestream Int'L, Inc.1
Medical Technique Instruments, Inc.1
North American Sterilization & Packaging Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order