510(k) K012198

GIBBONS STERILE TROCAR KITS by Gibbons Surgical Corp. — Product Code FBQ

K012198 is an FDA 510(k) premarket notification submitted by Gibbons Surgical Corp. for the device "GIBBONS STERILE TROCAR KITS". The FDA issued a decision of Substantially Equivalent on August 9, 2001. The device falls under product code FBQ (Trocar, Gastro-Urology), a Class II device regulated under 21 CFR 876.5090. Gibbons Surgical Corp. has at least 1 other 510(k) clearance on record.