Product code FBQ— Gastroenterology, Urology

FDA has cleared 9 devices under product code FBQ between 1984 and 2001, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20011 clearance
• 19981 clearance
• 19943 clearances
• 19931 clearance
• 19911 clearance
• 19901 clearance
• 19841 clearance

• United States Surgical, A Division of Tyco Healthc2 clearances
• Gabris Surgical Corp.2 clearances
• L.A.S.E.R., Inc.1 clearance
• Gibbons Surgical Corp.1 clearance
• Endotherapeutics1 clearance
• Endoscopic Concepts, Inc.1 clearance
• Aesculap, Inc.1 clearance

• K012198 — GIBBONS STERILE TROCAR KITSGibbons Surgical Corp.·2001-08-09
• K980804 — SABRE BT BLUNT0TIP SURGICAL TROCAREndoscopic Concepts, Inc.·1998-04-01
• K944640 — LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KITGabris Surgical Corp.·1994-10-11
• K944104 — GABRIS LAPAROSCOPIC SURGICAL KITSGabris Surgical Corp.·1994-09-13
• K942885 — AUTO SUTURE MODIFIED GRIPUnited States Surgical, A Division of Tyco Healthc·1994-08-22
• K934724 — AESCULAP TROCAR INSTRUMENT SETAesculap, Inc.·1993-12-23
• K904638 — TROCAR DISPOSABLEL.A.S.E.R., Inc.·1991-02-21
• K900123 — AUTO SUTURE SURGIPORT SPIRAL SLEEVEUnited States Surgical, A Division of Tyco Healthc·1990-04-04
• K841716 — ENDOPORT EROCAREndotherapeutics·1984-06-28