Product code GCQ— Gastroenterology, Urology

FDA has cleared 5 devices under product code GCQ between 1986 and 1993, filed by 4 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.

• 19931 clearance
• 19901 clearance
• 19872 clearances
• 19861 clearance

• Codman & Shurtleff, Inc.2 clearances
• Van-Tec, Inc.1 clearance
• Medical Laser, Inc.1 clearance
• Cooper Lasersonics, Inc.1 clearance

• K920979 — CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340)Codman & Shurtleff, Inc.·1993-03-23
• K900894 — MEDILASE SERIES 2100 ENDOSCOPEMedical Laser, Inc.·1990-06-22
• K871978 — CODMAN FLEXIBLE ENDOSCOPECodman & Shurtleff, Inc.·1987-08-25
• K864960 — TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.Cooper Lasersonics, Inc.·1987-02-10
• K860771 — VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPEVan-Tec, Inc.·1986-04-23