Product code GDF
- Device name
- Guide, Needle, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031173 | NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 | Needle Tech Products, Inc. | 2003-07-23 |
| K950311 | GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE | Global Medical Products, Ltd. | 1995-05-26 |
| K950007 | SURGICAL INSTRUMENT GUIDE | United States Surgical, A Division of Tyco Healthc | 1995-03-15 |
| K945124 | BREAST LESION LOCALIZATION NEEDLE | Promex, Inc. | 1994-11-22 |
| K944942 | BREAST LESION LOCALIZATION NEEDLE | Promedical , Ltd. | 1994-11-04 |
| K935538 | BAUER TEMNO COAXIAL NEEDLE | Bauer Medical, Inc. | 1994-02-22 |
| K935457 | LOCALIZATION WIRE OR MARKER - SURGICAL | Bip USA, Inc. | 1994-02-17 |
| K923840 | NEEDLE-GRABBER | Guardian Angel Products, Inc. | 1993-07-13 |
| K923835 | THE ELEVENTH FINGER | Guardian Angel Products, Inc. | 1993-07-09 |
| K925875 | HORIZONTAL NEEDLE GUIDE ATTACHMENT | Bip USA, Inc. | 1993-04-06 |
| K924270 | BREAST LESION LOCALIZATION NEEDLE | Core Medical, Inc. | 1992-09-23 |
| K923120 | MICROGUIDE LESION MARKING SYSTEM | Angiodynamics, Div. E-Z-Em, Inc. | 1992-09-01 |
| K914941 | SIMON BREAST LESION LOCALIZATION NEEDLE | Manan Medical Products, Inc. | 1992-05-14 |
| K920816 | PERCUGUIDE LESION MARKING | E-Z-Em, Inc. | 1992-04-21 |
| K904172 | ACCUPLACE (TM) | Dlp, Inc. | 1990-11-21 |
| K900903 | KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE | Milex Products, Inc. | 1990-05-03 |
| K890211 | MICROSURGICAL NEEDLE HOLDERS | Kinetic Medical Products | 1989-01-27 |
| K890228 | SURGICAL NEEDLE GUIDE | Kinetic Medical Products | 1989-01-27 |
| K890229 | SURGICAL NEEDLE HOLDERS | Kinetic Medical Products | 1989-01-27 |
| K882036 | WILLIAMS ACS MARKER NEEDLE | Buckman Co., Inc. | 1988-07-27 |
| K864551 | BIOPSY ADAPTER #H4221BG | General Electric Co. | 1986-12-23 |
| K863090 | PERCU GUIDE I (LOOP TYPE) | E-Z-Em, Inc. | 1986-08-29 |
| K861050 | BIOPSY ADAPTER H4222W | General Electric Co. | 1986-04-02 |
| K845038 | BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT | Ranfac, Corp. | 1985-03-11 |
| K832978 | MENISCAL SUTURE GUN | Instrument Makar, Inc. | 1983-12-12 |
| K821289 | MAYO-HEGAR NEEDLE HOLDER | Conphar, Inc. | 1982-06-03 |
| K821295 | OLSEN HEGAR NEEDLE HOLDERS | Conphar, Inc. | 1982-06-03 |
| K821354 | CONPHAR MAYO HEGAR NEEDLE HOLDER | Conphar, Inc. | 1982-06-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00851766006245 | PERL Localization Device, 16Ga x 11.5cm Needle | FOCAL THERAPEUTICS, INC. | 2019-07-16 |
| 00851766006184 | PERL Localization Device, 16Ga x 11.5cm Needle | FOCAL THERAPEUTICS, INC. | 2018-06-08 |
| 00851766006108 | PERL Localization Device, 16Ga x 11.5cm Needle | FOCAL THERAPEUTICS, INC. | 2017-08-01 |
| 00851766006092 | PERL Localization Device | FOCAL THERAPEUTICS, INC. | 2017-04-05 |
| 08032986359416 | AutoMark | M.D.L. S.R.L. | 2017-01-05 |
| 00801741079900 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079931 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079924 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079917 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079894 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079887 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079870 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079825 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079818 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079771 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079801 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079795 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079788 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079832 | GHIATAS® | Bard Peripheral Vascular, Inc. | 2016-09-16 |
| 00801741079962 | CHESBROUGH® | Bard Peripheral Vascular, Inc. | 2016-09-15 |
| 00801741079993 | ULTRAWIRE® | Bard Peripheral Vascular, Inc. | 2016-09-15 |
| 00801741079986 | ULTRAWIRE® | Bard Peripheral Vascular, Inc. | 2016-09-15 |
| 00801741079979 | ULTRAWIRE® | Bard Peripheral Vascular, Inc. | 2016-09-15 |
| 00801741079955 | CHESBROUGH® | Bard Peripheral Vascular, Inc. | 2016-09-15 |
| 00801741079948 | CHESBROUGH® | Bard Peripheral Vascular, Inc. | 2016-09-15 |
| 00801741079726 | DuaLok™ | Bard Peripheral Vascular, Inc. | 2016-09-13 |
| 00801741079764 | DuaLok™ | Bard Peripheral Vascular, Inc. | 2016-09-13 |
| 00801741079757 | DuaLok™ | Bard Peripheral Vascular, Inc. | 2016-09-13 |
| 00801741079740 | DuaLok™ | Bard Peripheral Vascular, Inc. | 2016-09-13 |
| 00801741079733 | DuaLok™ | Bard Peripheral Vascular, Inc. | 2016-09-13 |