Product code GCB— General, Plastic Surgery

FDA has cleared 8 devices under product code GCB between 1978 and 2015, filed by 7 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.

• 20151 clearance
• 19981 clearance
• 19931 clearance
• 19921 clearance
• 19901 clearance
• 19852 clearances
• 19781 clearance

• Medical Dynamics, Inc.2 clearances
• Symbiosis Corp.1 clearance
• Manan Manufacturing Co., Inc.1 clearance
• Jelco Laboratories1 clearance
• Concord Laboratories, Inc.1 clearance
• B.Braun Medical, Inc.1 clearance
• Allegiance Healthcare Corp.1 clearance

• K150800 — Valved Safety Centesis CatheterB.Braun Medical, Inc.·2015-11-12
• K974146 — PARACENTESIS CATHETER DEVICEAllegiance Healthcare Corp.·1998-01-28
• K930568 — ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.·1993-07-22
• K923028 — TURKEL PNEUMOTHORAX KITSymbiosis Corp.·1992-08-04
• K900374 — ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.·1990-04-20
• K854327 — SUBCUTANEOUS TUNNELING NEEDLES & HANDLESConcord Laboratories, Inc.·1985-11-13
• K852428 — MANAN EPIDURAL NEEDLEManan Manufacturing Co., Inc.·1985-06-27
• K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERSJelco Laboratories·1978-08-23