Bone & Marrow Collection System
FDA 510(k) K961901 · Biomedical Ent., Inc.
510(k) numberK961901
Submission
- Device name
- Bone & Marrow Collection System
- Applicant
- Biomedical Ent., Inc.
San Antonio, TX, US - Received
- May 16, 1996
- Decision date
- August 6, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K972308 | Mednext 1000 DrillGEY · Traditional | Mednext, Inc. | 08/20/1997SE |
| K971941 | Aqua SprayGEY · Traditional | Boyd Industries, Inc. | 08/14/1997SE |
| K971782 | Bone and Marrow Collection System KitGEY · Traditional | Biomedical Ent., Inc. | 07/29/1997SE |
| K971268 | Bone & Marrow Cllection SystemGEY · Traditional | Biomedical International Corp. | 07/03/1997SE |
| K964252 | OrthochuckGEY · Traditional | Buckman Co., Inc. | 05/27/1997SE |
| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
| K964073 | Bme Bone Drill BitsGEY · Traditional | Biomedical Ent., Inc. | 11/14/1996SE |
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| K001353 | Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for…HBW · Traditional | 03/13/2001SE |
| K001219 | Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple SystemJEY · Traditional | 06/21/2000SE |
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Questions and answers
When was Bone & Marrow Collection System cleared by the FDA?
Bone & Marrow Collection System (K961901) received a 510(k) decision of Substantially Equivalent on August 6, 1996, 82 days after the submission was received.
What is the product code of K961901?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.