Bioaccess Marrow Harvest System
FDA 510(k) K971114 · Bioaccess, Inc.
510(k) numberK971114
Submission
- Device name
- Bioaccess Marrow Harvest System
- Applicant
- Bioaccess, Inc.
Silver Spring, MD, US - Received
- March 26, 1997
- Decision date
- June 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code GDM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071732 | MarrowminerGDM · Traditional | Stemcor Systems, Inc. | 09/24/2007SE |
| 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 |
| K903749 | Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
More from Downs Surgical , Ltd.
Questions and answers
When was Bioaccess Marrow Harvest System cleared by the FDA?
Bioaccess Marrow Harvest System (K971114) received a 510(k) decision of Substantially Equivalent on June 3, 1997, 69 days after the submission was received.
What is the product code of K971114?
The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.