Product code GBQ— General, Plastic Surgery

FDA has cleared 8 devices under product code GBQ between 1977 and 1994, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19941 clearance
• 19921 clearance
• 19881 clearance
• 19873 clearances
• 19791 clearance
• 19771 clearance

• Trinity Laboratories, Inc.1 clearance
• Specialty Medical Products Co.1 clearance
• Quinton, Inc.1 clearance
• Jedmed Instrument Co.1 clearance
• Ipax, Inc.1 clearance
• Gesco Intl., Inc.1 clearance
• Concept, Inc.1 clearance
• Acumed Instruments Corp.1 clearance

• K941356 — MICROFLOW IRRIGATION SYSTEMJedmed Instrument Co.·1994-05-19
• K921464 — CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INTTrinity Laboratories, Inc.·1992-05-05
• K882647 — GESCO CATHETERIZATION TRAYGesco Intl., Inc.·1988-09-09
• K874596 — PERFORATED SOAKING TUBESpecialty Medical Products Co.·1987-12-02
• K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKSIpax, Inc.·1987-09-04
• K872787 — MODIFIED CURLCATHQuinton, Inc.·1987-08-04
• K791400 — GASTRIC LAVAGE KIT-DISPOSABLEAcumed Instruments Corp.·1979-08-16
• K771732 — THORNTON ANTERIOR CHAMBER IRRIGATORConcept, Inc.·1977-09-28