Product code GDF— General, Plastic Surgery

FDA has cleared 28 devices under product code GDF between 1982 and 2003, filed by 20 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.

• 20031 clearance
• 19952 clearances
• 19944 clearances
• 19933 clearances
• 19924 clearances
• 19902 clearances
• 19893 clearances
• 19881 clearance
• 19863 clearances
• 19851 clearance
• 19831 clearance
• 19823 clearances

• Kinetic Medical Products3 clearances
• Conphar, Inc.3 clearances
• Guardian Angel Products, Inc.2 clearances
• General Electric Co.2 clearances
• E-Z-Em, Inc.2 clearances
• Bip USA, Inc.2 clearances
• United States Surgical, A Division of Tyco Healthc1 clearance
• Ranfac, Corp.1 clearance
• Promex, Inc.1 clearance
• Promedical , Ltd.1 clearance

• K031173 — NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.·2003-07-23
• K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.·1995-05-26
• K950007 — SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco Healthc·1995-03-15
• K945124 — BREAST LESION LOCALIZATION NEEDLEPromex, Inc.·1994-11-22
• K944942 — BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.·1994-11-04
• K935538 — BAUER TEMNO COAXIAL NEEDLEBauer Medical, Inc.·1994-02-22
• K935457 — LOCALIZATION WIRE OR MARKER - SURGICALBip USA, Inc.·1994-02-17
• K923840 — NEEDLE-GRABBERGuardian Angel Products, Inc.·1993-07-13
• K923835 — THE ELEVENTH FINGERGuardian Angel Products, Inc.·1993-07-09
• K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENTBip USA, Inc.·1993-04-06
• K924270 — BREAST LESION LOCALIZATION NEEDLECore Medical, Inc.·1992-09-23
• K923120 — MICROGUIDE LESION MARKING SYSTEMAngiodynamics, Div. E-Z-Em, Inc.·1992-09-01
• K914941 — SIMON BREAST LESION LOCALIZATION NEEDLEManan Medical Products, Inc.·1992-05-14
• K920816 — PERCUGUIDE LESION MARKINGE-Z-Em, Inc.·1992-04-21
• K904172 — ACCUPLACE (TM)Dlp, Inc.·1990-11-21
• K900903 — KOPANS HOOKWIRE LESION LOCALIZATION NEEDLEMilex Products, Inc.·1990-05-03
• K890211 — MICROSURGICAL NEEDLE HOLDERSKinetic Medical Products·1989-01-27
• K890228 — SURGICAL NEEDLE GUIDEKinetic Medical Products·1989-01-27
• K890229 — SURGICAL NEEDLE HOLDERSKinetic Medical Products·1989-01-27
• K882036 — WILLIAMS ACS MARKER NEEDLEBuckman Co., Inc.·1988-07-27
• K864551 — BIOPSY ADAPTER #H4221BGGeneral Electric Co.·1986-12-23
• K863090 — PERCU GUIDE I (LOOP TYPE)E-Z-Em, Inc.·1986-08-29
• K861050 — BIOPSY ADAPTER H4222WGeneral Electric Co.·1986-04-02
• K845038 — BREAST & FOREIGN BODY LOCALIZATION INSTRUMENTRanfac, Corp.·1985-03-11
• K832978 — MENISCAL SUTURE GUNInstrument Makar, Inc.·1983-12-12
• K821289 — MAYO-HEGAR NEEDLE HOLDERConphar, Inc.·1982-06-03
• K821295 — OLSEN HEGAR NEEDLE HOLDERSConphar, Inc.·1982-06-03
• K821354 — CONPHAR MAYO HEGAR NEEDLE HOLDERConphar, Inc.·1982-06-03