Product code GBS— General, Plastic Surgery

FDA has cleared 27 devices under product code GBS between 1980 and 1991, filed by 18 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.

• 19911 clearance
• 19891 clearance
• 19883 clearances
• 19875 clearances
• 19865 clearances
• 19854 clearances
• 19841 clearance
• 19831 clearance
• 19823 clearances
• 19812 clearances
• 19801 clearance

• H.W. Andersen Products, Inc.3 clearances
• Axiom Medical, Inc.3 clearances
• Uresil Corp.2 clearances
• Sil-Med Corp.2 clearances
• Sherwood Medical Co.2 clearances
• Sheridan Catheter Corp.2 clearances
• C.R. Bard, Inc.2 clearances
• Treace Medical, Inc.1 clearance
• Texas Medical Products, Inc.1 clearance
• Snyder Laboratories, Inc.1 clearance

• K912645 — ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp.·1991-09-13
• K883887 — AXIOM ATRAUM WOUND DRAINSAxiom, Inc.·1989-02-17
• K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESSSheridan Catheter Corp.·1988-05-18
• K880895 — URESIL WOUND DRAIN TROCARUresil Corp.·1988-03-14
• K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.·1988-02-16
• K873377 — CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, Inc.·1987-10-28
• K872460 — AN3000 MAHONEY DRAINH.W. Andersen Products, Inc.·1987-07-23
• K872457 — AN3500 WORTH DRAINH.W. Andersen Products, Inc.·1987-07-21
• K872459 — AN3100 MULHOLLAND DRAINH.W. Andersen Products, Inc.·1987-07-21
• K870015 — HCI ALL PURPOSE DRAIN/CATHETER SETHealth Care Innovations, Inc.·1987-02-06
• K863560 — URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRAUresil Corp.·1986-09-29
• K863142 — THORACIC CATHETER (CHEST DRAINAGE TUBE)Sheridan Catheter Corp.·1986-08-29
• K863247 — AXIOM TROCAR THORACIC CATHETERAxiom Medical, Inc.·1986-08-29
• K862584 — OSTEOTOMY DRAINAGE TUBETreace Medical, Inc.·1986-08-12
• K862767 — SILICONE SUMP DRAINSil-Med Corp.·1986-08-07
• K854418 — ROUND SUCTION DRAINSil-Med Corp.·1985-11-19
• K853131 — THORO/CATH STRAIGHT THORACIC RIGHT ANGLEJ. H. Emerson Co.·1985-09-05
• K852241 — AXIOM ATRAUM TROCAR CATHETERAxiom Medical, Inc.·1985-06-14
• K851048 — CHEST CATHETERS/THORACIC CATHETERSMedovations, Inc.·1985-06-05
• K843906 — SNYDER HEMOVAC WOUND DRAINAGE DEVICESSnyder Laboratories, Inc.·1984-11-05
• K832416 — AXIOM HYDROMER WOUND DRAINSAxiom Medical, Inc.·1983-10-31
• K822318 — ARGYLE MEDIASTINAL DRAINSherwood Medical Co.·1982-08-27
• K813463 — SIL-V-UR CHEST CATHETERC.R. Bard, Inc.·1982-02-12
• K813587 — DISPOSABLE THORACIC CATHETERTexas Medical Products, Inc.·1982-01-12
• K810158 — DAVOL SILICONE SHEATH SUMP DRAINC.R. Bard, Inc.·1981-02-13
• K810071 — STERILE SILICONE TUBINGMedspec Corp.·1981-02-12
• K802318 — ARGYLE SILICONE THORACIC CATHETERSherwood Medical Co.·1980-10-23