Product code DWO— General, Plastic Surgery

FDA has cleared 11 devices under product code DWO between 1982 and 1994, filed by 10 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
• 19911 clearance
• 19893 clearances
• 19881 clearance
• 19872 clearances
• 19851 clearance
• 19821 clearance

• Hart Enterprises, Inc.2 clearances
• Vlv Associates, Inc.1 clearance
• Ocean Medical Products, Ltd.1 clearance
• Medsurg Industries, Inc.1 clearance
• Medical Device Technologies, Inc.1 clearance
• Manan Medical Products, Inc.1 clearance
• Dianon Systems, Inc.1 clearance
• CIVCO Medical Instruments Co., Inc.1 clearance
• Argon Medical Corp.1 clearance
• Angiomed U.S., Inc.1 clearance

• K933364 — PROMED BIOPSY NEEDLEVlv Associates, Inc.·1994-02-15
• K921418 — ULTRA-CORE BIOPSY NEEDLESMedical Device Technologies, Inc.·1992-06-19
• K913815 — AUTOMATED BIOPSY DEVICE, MODIFICATIONHart Enterprises, Inc.·1991-10-30
• K890925 — MANAN BONE MARROW BIOPSY NEEDLEManan Medical Products, Inc.·1989-04-11
• K885145 — MEDSURG GREENE NEEDLEMedsurg Industries, Inc.·1989-03-14
• K885149 — NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICEHart Enterprises, Inc.·1989-01-26
• K882013 — SOFT TISSUE BIOPSY DEVICEOcean Medical Products, Ltd.·1988-06-15
• K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLEAngiomed U.S., Inc.·1987-12-02
• K872597 — FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATEDianon Systems, Inc.·1987-07-28
• K853312 — ARGON CUT BIOPSY NEEDLES, VARIOUS SIZESArgon Medical Corp.·1985-09-12
• K820269 — RNG SERIES ULTRASOUND NEEDLE/CATH. GDSCIVCO Medical Instruments Co., Inc.·1982-03-23