Medical Device Manufacturer · US , Norcross , GA

Solos Endoscopy, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1990

Recent clearances: MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY, MODEL GS-4700 COMMON DUCT STONE REMOVING KIT, GS-1000 GRASPING FORCEP, 5MM, INSULATED

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Solos Endoscopy, Inc. Gastroenterology & Urology ✕

7 devices

1-7 of 7

Cleared May 10, 1991

MODEL GS-4700 COMMON DUCT STONE REMOVING KIT

Gastroenterology & Urology · 84d

Cleared Apr 18, 1990

GS-4000 REDUCER SLEEVE, 11MM TO 5MM

Gastroenterology & Urology · 50d

Cleared Apr 18, 1990

GS-4100 REDUCER SLEEVE, 5MM TO 3MM

Gastroenterology & Urology · 50d

Cleared Apr 18, 1990

GS-4300 CANNULA AND TROCAR, 5.5MM

Gastroenterology & Urology · 50d

Cleared Apr 18, 1990

GS-4350 TROCAR ONLY, 5.5MM

Gastroenterology & Urology · 50d

Cleared Apr 18, 1990

CANNULA AND TROCAR, 11MM

Gastroenterology & Urology · 50d

Cleared Apr 18, 1990

GS-4550 TROCAR ONLY, 11MM

Gastroenterology & Urology · 50d