Becton Dickinson Modified Menghini Needle
FDA 510(k) K915572 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK915572
Submission
- Device name
- Becton Dickinson Modified Menghini Needle
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- December 12, 1991
- Decision date
- February 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GDM – Needle, Aspiration And Injection, Reusable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071732 | MarrowminerGDM · Traditional | Stemcor Systems, Inc. | 09/24/2007SE |
| K971114 | Bioaccess Marrow Harvest SystemGDM · Traditional | Bioaccess, Inc. | 06/03/1997SE |
| K953082 | Iliac Crest Bone Marrow Aspiration NeedleGDM · Traditional | Baxter Healthcare Corp | 09/22/1995SE |
| K953064 | Bioaccess Marrow Harvest SystemGDM · Traditional | Bioaccess, Inc. | 08/07/1995SE |
| K936207 | Endo-Needle InstrumentGDM · Traditional | Gerard Medical, Inc. | 06/16/1994SE |
| K930160 | Illinois Sternal/Iliac Aspiration NeedleGDM · Traditional | Symbiosis Corp. | 07/06/1993SE |
| K923872 | Bone Marrow Biopsy SystemGDM · Traditional | The Straumann Co. | 12/15/1992SE |
| K904667 | Na NeedlesGDM · Traditional | Olympus Corp. | 12/12/1990SE |
| K903750 | Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
| K903749 | Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
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| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | 06/06/2001SE |
| K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional | 03/21/2001SE |
| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Becton Dickinson Modified Menghini Needle cleared by the FDA?
Becton Dickinson Modified Menghini Needle (K915572) received a 510(k) decision of Substantially Equivalent on February 3, 1992, 53 days after the submission was received.
What is the product code of K915572?
The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.