GDF — Guide, Needle, Surgical Class I
FDA product code GDF covers "Guide, Needle, Surgical", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GDF
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K031173 | needle tech products | NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4001 | July 23, 2003 |
| K950311 | global medical products | GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE | May 26, 1995 |
| K950007 | united states surgical, a division of tyco healthc | SURGICAL INSTRUMENT GUIDE | March 15, 1995 |
| K945124 | promex | BREAST LESION LOCALIZATION NEEDLE | November 22, 1994 |
| K944942 | promedical | BREAST LESION LOCALIZATION NEEDLE | November 4, 1994 |
| K935538 | bauer medical | BAUER TEMNO COAXIAL NEEDLE | February 22, 1994 |
| K935457 | bip usa | LOCALIZATION WIRE OR MARKER - SURGICAL | February 17, 1994 |
| K923840 | guardian angel products | NEEDLE-GRABBER | July 13, 1993 |
| K923835 | guardian angel products | THE ELEVENTH FINGER | July 9, 1993 |
| K925875 | bip usa | HORIZONTAL NEEDLE GUIDE ATTACHMENT | April 6, 1993 |
| K924270 | core medical | BREAST LESION LOCALIZATION NEEDLE | September 23, 1992 |
| K923120 | angiodynamics, div. e-z-em | MICROGUIDE LESION MARKING SYSTEM | September 1, 1992 |
| K914941 | manan medical products | SIMON BREAST LESION LOCALIZATION NEEDLE | May 14, 1992 |
| K920816 | e-z-em | PERCUGUIDE LESION MARKING | April 21, 1992 |
| K904172 | dlp | ACCUPLACE (TM) | November 21, 1990 |
| K900903 | milex products | KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE | May 3, 1990 |
| K890211 | kinetic medical products | MICROSURGICAL NEEDLE HOLDERS | January 27, 1989 |
| K890228 | kinetic medical products | SURGICAL NEEDLE GUIDE | January 27, 1989 |
| K890229 | kinetic medical products | SURGICAL NEEDLE HOLDERS | January 27, 1989 |
| K882036 | buckman co | WILLIAMS ACS MARKER NEEDLE | July 27, 1988 |