DeviceClearance

Product code HMT— General, Plastic Surgery

DRAIN-R-DRAPE(EYE

Classification name
Drape, Patient, Ophthalmic
Device class
Class 2
Regulation
21 CFR 878.4370
Advisory panel
General, Plastic Surgery
Total cleared
7
First cleared
Most recent

Market context for product code HMT

FDA has cleared 7 devices under product code HMT between 1983 and 1995, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code HMT

Recent clearances under product code HMT

Data sourced from openFDA. This site is unofficial and independent of the FDA.