HNM · Class I · 21 CFR 886.4350

FDA Product Code HNM: Needle, Ophthalmic Suturing

Leading manufacturers include Edward Weck, Inc. and Optical Micro Systems, Inc..

2
Total
2
Cleared
162d
Avg days
1978
Since

FDA 510(k) Cleared Needle, Ophthalmic Suturing Devices (Product Code HNM)

2 devices
1–2 of 2
Cleared Aug 21, 1985
OMS/GONVERS RETINAL PERFORATOR
K844448
Optical Micro Systems, Inc.
Ophthalmic · 278d
Cleared Mar 17, 1978
NEEDLEHOLDER, MICROVASULAR 5 1/2
K780154
Edward Weck, Inc.
Ophthalmic · 46d

About Product Code HNM - Regulatory Context