FGS — Carrier, Sponge, Endoscopic Class II

FDA Device Classification

FDA product code FGS covers "Carrier, Sponge, Endoscopic", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FGS
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K933604joyce m. shotwell, m.dQB II BLUNT DISSECTORSeptember 23, 1993
K931854mayaguez medical centerENDOSCOPIC BLUNT DISSECTING INSTRUMENTAugust 10, 1993
K923818o.r. conceptsO.R. CONCEPTS' IRRIGATING KITTNERApril 7, 1993
K822194kelleherENDOSCOPIC SPONGE CARRIERAugust 27, 1982