Product code GDM
- Device name
- Needle, Aspiration And Injection, Reusable
- 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 |
|---|---|---|---|
| K071732 | MARROWMINER | Stemcor Systems, Inc. | 2007-09-24 |
| K971114 | BIOACCESS MARROW HARVEST SYSTEM | Bioaccess, Inc. | 1997-06-03 |
| K953082 | ILIAC CREST BONE MARROW ASPIRATION NEEDLE | Baxter Healthcare Corp | 1995-09-22 |
| K953064 | BIOACCESS MARROW HARVEST SYSTEM | Bioaccess, Inc. | 1995-08-07 |
| K936207 | ENDO-NEEDLE INSTRUMENT | Gerard Medical, Inc. | 1994-06-16 |
| K930160 | ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE | Symbiosis Corp. | 1993-07-06 |
| K923872 | BONE MARROW BIOPSY SYSTEM | The Straumann Co. | 1992-12-15 |
| K915572 | BECTON DICKINSON MODIFIED MENGHINI NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-02-03 |
| K904667 | NA NEEDLES | Olympus Corp. | 1990-12-12 |
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | Downs Surgical , Ltd. | 1990-10-31 |
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | Downs Surgical , Ltd. | 1990-10-31 |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | Downs Surgical , Ltd. | 1990-10-31 |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | Downs Surgical , Ltd. | 1990-10-31 |
| K902177 | MANAN BONE BIOPSY NEEDLE | Manan Medical Products, Inc. | 1990-09-05 |
| K901995 | PLEURA BIOPSY DEVICE | Mill-Rose Laboratory | 1990-07-10 |
| K895752 | DIAMOND BLADE SURGICAL KNIVES | Magnum Diamond, Inc. | 1989-10-17 |
| K895594 | SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE | Go Medical Industries Pty. , Ltd. | 1989-10-06 |
| K895551 | ROCKET BONE MARROW NEEDLE | A & A Medical, Inc. | 1989-10-06 |
| K890722 | ADG BONE BIOPSY SYSTEM | American Design Group, Inc. | 1989-09-21 |
| K891537 | CORE BIOPSY NEEDLE, CATALOG CODE #54006 | Dlp, Inc. | 1989-04-18 |
| K885283 | ASPIRATING AND IRRIGATING CYSTS NEEDLES | Go Medical Industries Pty. , Ltd. | 1989-03-22 |
| K881783 | KLEIN HANDLE | E.L. Medico Intl., Inc. | 1988-12-02 |
| K881784 | KLEIN NEEDLE | E.L. Medico Intl., Inc. | 1988-12-02 |
| K883876 | WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE | E.G. Dick & Assoc. | 1988-10-07 |
| K881624 | PLEURAL BIOPSY PUNCH NEEDLE | E.G. Dick & Assoc. | 1988-08-11 |
| K882240 | STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC | Storz Instrument Co. | 1988-07-29 |
| K882601 | E-Z-EM(R) LUFKIN BIOPSY NEEDLES | E-Z-Em, Inc. | 1988-07-25 |
| K882073 | SPINAL NEEDLE | Karlin Technology, Inc. | 1988-07-18 |
| K881730 | BREAST LOCALIZATION NEEDLES | Hart Enterprises, Inc. | 1988-05-13 |
| K880812 | SPINAL NEEDLE | T. Korossurgical Instruments Corp. | 1988-03-11 |
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|---|---|---|---|
| 00840516145884 | Anodyne Surgical | Psi/Eye-Ko, Inc. | 2026-06-02 |
| 00810130456376 | Medco Manufacturing | Medco Manufacturing LLC | 2026-05-29 |
| 00810130456383 | Medco Manufacturing | Medco Manufacturing LLC | 2026-05-29 |
| 14026704934598 | PILLING | TELEFLEX INCORPORATED | 2026-03-06 |
| 14026704934604 | PILLING | TELEFLEX INCORPORATED | 2026-03-06 |
| 14026704934611 | PILLING | TELEFLEX INCORPORATED | 2026-03-06 |
| 00194613093167 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2024-08-15 |
| 00194613045791 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2024-08-15 |
| 10381780539810 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780540113 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780539827 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780539803 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780539797 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780539780 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 14026704921192 | PILLING | TELEFLEX INCORPORATED | 2024-02-15 |
| 14026704921222 | PILLING | TELEFLEX INCORPORATED | 2024-02-13 |
| 14026704916891 | PILLING | TELEFLEX INCORPORATED | 2023-11-03 |
| 14026704916921 | PILLING | TELEFLEX INCORPORATED | 2023-11-03 |
| 00810130450015 | Medco Manufacturing | Medco Manufacturing LLC | 2023-01-26 |
| M6335375720 | JEDMED | JEDMED INSTRUMENT COMPANY | 2023-01-19 |
| M6335375710 | JEDMED | JEDMED INSTRUMENT COMPANY | 2023-01-19 |
| 14026704811042 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704802255 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 08717872003900 | Replacement backflush Reservoir for 1281.E. | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-09 |
| 08717872003795 | Replacement Backflush Needle with silicone tip, straight. | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-02 |
| 00810055470402 | Instrumentarium | Société Chirurgicale Instrumentarium Inc | 2020-08-24 |
| 00810055470433 | Instrumentarium | Société Chirurgicale Instrumentarium Inc | 2020-08-24 |
| 00810055470518 | Instrumentarium | Société Chirurgicale Instrumentarium Inc | 2020-08-24 |
| 00192896070219 | CARDIOPLEGIA NEEDLE | SONTEC INSTRUMENTS, INC. | 2018-09-06 |
| 00192896070226 | CARDIOPLEGIA NEEDLE | SONTEC INSTRUMENTS, INC. | 2018-09-06 |