GDM — Needle, Aspiration And Injection, Reusable Class I
FDA product code GDM covers "Needle, Aspiration And Injection, Reusable", 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
- GDM
- 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 |
|---|---|---|---|
| K071732 | stemcor systems | MARROWMINER | September 24, 2007 |
| K971114 | bioaccess | BIOACCESS MARROW HARVEST SYSTEM | June 3, 1997 |
| K953082 | baxter healthcare | ILIAC CREST BONE MARROW ASPIRATION NEEDLE | September 22, 1995 |
| K953064 | bioaccess | BIOACCESS MARROW HARVEST SYSTEM | August 7, 1995 |
| K936207 | gerard medical | ENDO-NEEDLE INSTRUMENT | June 16, 1994 |
| K930160 | symbiosis | ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE | July 6, 1993 |
| K923872 | straumann | BONE MARROW BIOPSY SYSTEM | December 15, 1992 |
| K915572 | bd becton dickinson vacutainer systems preanalytic | BECTON DICKINSON MODIFIED MENGHINI NEEDLE | February 3, 1992 |
| K904667 | olympus | NA NEEDLES | December 12, 1990 |
| K903747 | downs surgical | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | October 31, 1990 |
| K903750 | downs surgical | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | October 31, 1990 |
| K903748 | downs surgical | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | October 31, 1990 |
| K903749 | downs surgical | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | October 31, 1990 |
| K902177 | manan medical products | MANAN BONE BIOPSY NEEDLE | September 5, 1990 |
| K901995 | mill-rose laboratory | PLEURA BIOPSY DEVICE | July 10, 1990 |
| K895752 | magnum diamond | DIAMOND BLADE SURGICAL KNIVES | October 17, 1989 |
| K895551 | a and a medical | ROCKET BONE MARROW NEEDLE | October 6, 1989 |
| K895594 | go medical industries pty. | SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE | October 6, 1989 |
| K890722 | american design group | ADG BONE BIOPSY SYSTEM | September 21, 1989 |
| K891537 | dlp | CORE BIOPSY NEEDLE, CATALOG CODE #54006 | April 18, 1989 |