Atlas FDA

GDF

28 FDA 510(k) clearances · Product code

71 daysmedian time to decision
192 days90th percentile
28clearances measured

FDA profile

Official device name
Guide, Needle, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2016: 15 · 2019: 13 · 2020: 14 · 2024: 16 · 2025: 19 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 (K031173)Needle Tech Products, Inc.2003-07-23
GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (K950311)Global Medical Products, Ltd.1995-05-26
SURGICAL INSTRUMENT GUIDE (K950007)United States Surgical, A Division of Tyco Healthc1995-03-15
BREAST LESION LOCALIZATION NEEDLE (K945124)Promex, Inc.1994-11-22
BREAST LESION LOCALIZATION NEEDLE (K944942)Promedical , Ltd.1994-11-04
BAUER TEMNO COAXIAL NEEDLE (K935538)Bauer Medical, Inc.1994-02-22
LOCALIZATION WIRE OR MARKER - SURGICAL (K935457)Bip USA, Inc.1994-02-17
NEEDLE-GRABBER (K923840)Guardian Angel Products, Inc.1993-07-13
THE ELEVENTH FINGER (K923835)Guardian Angel Products, Inc.1993-07-09
HORIZONTAL NEEDLE GUIDE ATTACHMENT (K925875)Bip USA, Inc.1993-04-06
BREAST LESION LOCALIZATION NEEDLE (K924270)Core Medical, Inc.1992-09-23
MICROGUIDE LESION MARKING SYSTEM (K923120)Angiodynamics, Div. E-Z-Em, Inc.1992-09-01
SIMON BREAST LESION LOCALIZATION NEEDLE (K914941)Manan Medical Products, Inc.1992-05-14
PERCUGUIDE LESION MARKING (K920816)E-Z-Em, Inc.1992-04-21
ACCUPLACE (TM) (K904172)Dlp, Inc.1990-11-21
KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE (K900903)Milex Products, Inc.1990-05-03
MICROSURGICAL NEEDLE HOLDERS (K890211)Kinetic Medical Products1989-01-27
SURGICAL NEEDLE HOLDERS (K890229)Kinetic Medical Products1989-01-27
SURGICAL NEEDLE GUIDE (K890228)Kinetic Medical Products1989-01-27
WILLIAMS ACS MARKER NEEDLE (K882036)Buckman Co., Inc.1988-07-27
BIOPSY ADAPTER #H4221BG (K864551)General Electric Co.1986-12-23
PERCU GUIDE I (LOOP TYPE) (K863090)E-Z-Em, Inc.1986-08-29
BIOPSY ADAPTER H4222W (K861050)General Electric Co.1986-04-02
BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT (K845038)Ranfac, Corp.1985-03-11
MENISCAL SUTURE GUN (K832978)Instrument Makar, Inc.1983-12-12
CONPHAR MAYO HEGAR NEEDLE HOLDER (K821354)Conphar, Inc.1982-06-03
MAYO-HEGAR NEEDLE HOLDER (K821289)Conphar, Inc.1982-06-03
OLSEN HEGAR NEEDLE HOLDERS (K821295)Conphar, Inc.1982-06-03

Track GDF automatically

Every clearance here is in the API, with alerts when new ones post.