Angiomed Vac-U-Cut Biopsy Needle
FDA 510(k) K862805 · Angiomed U.S., Inc.
510(k) numberK862805
Submission
- Device name
- Angiomed Vac-U-Cut Biopsy Needle
- Applicant
- Angiomed U.S., Inc.
Anaheim, CA, US - Received
- July 22, 1986
- Decision date
- September 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| 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 |
| K915572 | Becton Dickinson Modified Menghini NeedleGDM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/03/1992SE |
| 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 |
More from Downs Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K874771 | Angiomed Introducing SetsDWB · Traditional | 01/12/1988SE |
| K874585 | Angiomed Osty-Cut Bone Biopsy NeedleDWO · Traditional | 12/02/1987SE |
| K864225 | Angiomed Ureteral D&M Sets/Ureteroscopy Guid StentFAD · Traditional | 01/30/1987SE |
| K863386 | Vesico Suprapubic Bladder Drainage & Exchange SetsKOB · Traditional | 10/24/1986SE |
| K863446 | Angiomed High Pressure ConnectorsGCD · Traditional | 09/23/1986SE |
| K854910 | AngioflowDQO · Traditional | 07/17/1986SE |
| K854912 | Angiomed Guied WiresDQX · Traditional | 04/16/1986SE |
| K854908 | UroflexFAD · Traditional | 03/14/1986SE |
| K855143 | Angiomed Exchange Drainage Catheter SetsKOD · Traditional | 03/11/1986SE |
| K855142 | Angiomed Percutaneous Transhepatic CholangiogtaphyFGE · Traditional | 03/11/1986SE |
Questions and answers
When was Angiomed Vac-U-Cut Biopsy Needle cleared by the FDA?
Angiomed Vac-U-Cut Biopsy Needle (K862805) received a 510(k) decision of Substantially Equivalent on September 29, 1986, 69 days after the submission was received.
What is the product code of K862805?
The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.