Medical Device Manufacturer · US , Sharon , MA

Woodbine Optical Corp. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1994

Recent clearances: SOLOS 10MM OPERATING LAPAROSCOPE, SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Woodbine Optical Corp. General & Plastic Surgery ✕

5 devices

1-5 of 5

Cleared Jun 10, 1997

SOLOS 10MM OPERATING LAPAROSCOPE

General & Plastic Surgery · 90d

Cleared Jan 28, 1997

SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES

General & Plastic Surgery · 21d

Cleared Sep 22, 1995

WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA

General & Plastic Surgery · 81d

Cleared Jun 16, 1995

WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA

General & Plastic Surgery · 74d

Cleared Jun 10, 1994

ACCESSORIES, SURGICAL CAMERA

General & Plastic Surgery · 98d