Medical Device Manufacturer · US , Sturbridge , MA

Netoptix Corp. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1997

Recent clearances: LEISEGANG VIDEO COLPOSCOPE, GALILEO DISPOSABLE HYSTEROSCOPES, GALILEO DISPOSABLE HYSTEROSCOPES

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Netoptix Corp. Obstetrics & Gynecology ✕

4 devices

1-4 of 4

Cleared Oct 19, 1998

LEISEGANG VIDEO COLPOSCOPE

Obstetrics & Gynecology · 137d

Cleared Jul 07, 1998

GALILEO DISPOSABLE HYSTEROSCOPES

Obstetrics & Gynecology · 46d

Cleared Feb 13, 1998

GALILEO DISPOSABLE HYSTEROSCOPES

Obstetrics & Gynecology · 88d

Cleared Oct 10, 1997

GALILEO HIGH RESOLUTION MICRO COUPLER

Obstetrics & Gynecology · 141d