FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BONE & MARROW COLLECTION SYSTEM
K Number: K961901
·
Decision Aug 6, 1996
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
40
Applicant Total
13
Review Days
82
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Basic Information
- Device Name
- BONE & MARROW COLLECTION SYSTEM
- K Number
- K961901
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biomedical Ent., Inc.
- Date Received
- May 16, 1996
- Decision Date
- August 6, 1996
- Product Code
- GEY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Biomedical Ent., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133844 | SPEED TRIAD | Apr 7, 2014 | Substantially Equivalent |
| K133780 | SPEED XL | Mar 19, 2014 | Substantially Equivalent |
| K131640 | SMOOTH OR THREADED METALLIC BONE FASTENER | Oct 16, 2013 | Substantially Equivalent |
| K102107 | OSSTAPLE CHILL | Sep 3, 2010 | Substantially Equivalent |
| K091951 | HAMMERLOCK | Feb 19, 2010 | Substantially Equivalent |
| K023203 | OSSTAPLE | Oct 17, 2002 | Substantially Equivalent |
| K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM | Mar 13, 2001 | Substantially Equivalent |
| K001354 | MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM | Mar 13, 2001 | Substantially Equivalent |
| K001219 | MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM | Jun 21, 2000 | Substantially Equivalent |
| K993714 | MEMOGRAPH STAPLE, WARM SYSTEM | Feb 25, 2000 | Substantially Equivalent |