FDA Product Code
FDA Product Code GDF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K031173 | NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 | Needle Tech Products, Inc. | 2003-07-23 | Traditional | PDF ↗ |
| K950311 | GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE | Global Medical Products, Ltd. | 1995-05-26 | Traditional | PDF ↗ |
| K950007 | SURGICAL INSTRUMENT GUIDE | United States Surgical, A Division of Tyco Healthc | 1995-03-15 | Traditional | PDF ↗ |
| K945124 | BREAST LESION LOCALIZATION NEEDLE | Promex, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K944942 | BREAST LESION LOCALIZATION NEEDLE | Promedical , Ltd. | 1994-11-04 | Traditional | PDF ↗ |
| K935538 | BAUER TEMNO COAXIAL NEEDLE | Bauer Medical, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K935457 | LOCALIZATION WIRE OR MARKER - SURGICAL | Bip USA, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K923840 | NEEDLE-GRABBER | Guardian Angel Products, Inc. | 1993-07-13 | Traditional | PDF ↗ |
| K923835 | THE ELEVENTH FINGER | Guardian Angel Products, Inc. | 1993-07-09 | Traditional | PDF ↗ |
| K925875 | HORIZONTAL NEEDLE GUIDE ATTACHMENT | Bip USA, Inc. | 1993-04-06 | Traditional | PDF ↗ |
| K924270 | BREAST LESION LOCALIZATION NEEDLE | Core Medical, Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K923120 | MICROGUIDE LESION MARKING SYSTEM | Angiodynamics, Div. E-Z-Em, Inc. | 1992-09-01 | Traditional | PDF ↗ |
| K914941 | SIMON BREAST LESION LOCALIZATION NEEDLE | Manan Medical Products, Inc. | 1992-05-14 | Traditional | PDF ↗ |
| K920816 | PERCUGUIDE LESION MARKING | E-Z-Em, Inc. | 1992-04-21 | Traditional | PDF ↗ |
| K904172 | ACCUPLACE (TM) | Dlp, Inc. | 1990-11-21 | Traditional | PDF ↗ |
| K900903 | KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE | Milex Products, Inc. | 1990-05-03 | Traditional | PDF ↗ |
| K890228 | SURGICAL NEEDLE GUIDE | Kinetic Medical Products | 1989-01-27 | Traditional | PDF ↗ |
| K890229 | SURGICAL NEEDLE HOLDERS | Kinetic Medical Products | 1989-01-27 | Traditional | PDF ↗ |
| K890211 | MICROSURGICAL NEEDLE HOLDERS | Kinetic Medical Products | 1989-01-27 | Traditional | PDF ↗ |
| K882036 | WILLIAMS ACS MARKER NEEDLE | Buckman Co., Inc. | 1988-07-27 | Traditional | PDF ↗ |
| K864551 | BIOPSY ADAPTER #H4221BG | General Electric Co. | 1986-12-23 | Traditional | PDF ↗ |
| K863090 | PERCU GUIDE I (LOOP TYPE) | E-Z-Em, Inc. | 1986-08-29 | Traditional | PDF ↗ |
| K861050 | BIOPSY ADAPTER H4222W | General Electric Co. | 1986-04-02 | Traditional | PDF ↗ |
| K845038 | BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT | Ranfac, Corp. | 1985-03-11 | Traditional | PDF ↗ |
| K832978 | MENISCAL SUTURE GUN | Instrument Makar, Inc. | 1983-12-12 | Traditional | PDF ↗ |
| K821289 | MAYO-HEGAR NEEDLE HOLDER | Conphar, Inc. | 1982-06-03 | Traditional | PDF ↗ |
| K821295 | OLSEN HEGAR NEEDLE HOLDERS | Conphar, Inc. | 1982-06-03 | Traditional | PDF ↗ |
| K821354 | CONPHAR MAYO HEGAR NEEDLE HOLDER | Conphar, Inc. | 1982-06-03 | Traditional | PDF ↗ |
Product code GDF · Class I · General, Plastic Surgery. Data: openFDA.