510(k) K971114
- Device
- BIOACCESS MARROW HARVEST SYSTEM
- Applicant
- BIOACCESS, INC.
- 510(k) number
- K971114
- Product code
- GDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-03
- Date received
- 1997-03-26
- Regulation
- 878.4800
- Classification name
- Needle, Aspiration And Injection, Reusable
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER J CARNES
- Address
- 8400 Cedar St. Silver Spring MD US 20910 20910
FDA Registration Numbers#
- 3003687489
- 9611112
- 3005440795
- 3004215117
- 9615857
- 1625425
- 2011171
- 1421879
- 1056350
- 2511556
- 3003761012
- 8040278
- 3005064943
- 8010099
- 3010041511
- 3014615697
- 3008797953
- 9611283
- 1929756
- 3004111573
- 3007597038
- 1313525
- 1417485
- 3003244954
- 3012507533
- 3009255580
- 2521453
- 3024988980
- 3012267976
- 1450662
- 3008514120
- 3004001706
- 1836161
- 3002858762
- 3011050570
- 3035708926
- 9680515
- 3040389299
- 9611516
- 9680837
- 3016248634
- 1424263
- 2529846
- 8044098
- 8043368
- 2434839
- 3003418325
- 3004365956
- 3006611221
- 3033536312
- 2126670
- 3030839824
- 3013497507
- 1423507
- 3013557562
- 2085199
- 9616250
- 1828424
- 3011137372
- 1646747
- 3010202439
- 3007137643
- 8010257
- 1417592
- 3013055489
- 2030580
- 1644312
- 2243072
- 9610849
- 3005987240
- 8040233
- 2916714
- 3003431869
- 5906
- 3015143057
- 9612074
- 2029015
- 3006897996
- 3005528784
Source Documents#
Other 510(k) Records For Product Code GDM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071732 | MARROWMINER | Stemcor Systems, Inc. | 2007-09-24 |
| K953082 | ILIAC CREST BONE MARROW ASPIRATION NEEDLE | Baxter Healthcare Corp | 1995-09-22 |
| K953064 | BIOACCESS MARROW HARVEST SYSTEM | Bioaccess, Inc. | 1995-08-07 |
| K936207 | ENDO-NEEDLE INSTRUMENT | Gerard Medical, Inc. | 1994-06-16 |
| K930160 | ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE | Symbiosis Corp. | 1993-07-06 |
| K923872 | BONE MARROW BIOPSY SYSTEM | The Straumann Co. | 1992-12-15 |
| K915572 | BECTON DICKINSON MODIFIED MENGHINI NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-02-03 |
| K904667 | NA NEEDLES | Olympus Corp. | 1990-12-12 |
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | Downs Surgical , Ltd. | 1990-10-31 |
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | Downs Surgical , Ltd. | 1990-10-31 |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | Downs Surgical , Ltd. | 1990-10-31 |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | Downs Surgical , Ltd. | 1990-10-31 |
| K902177 | MANAN BONE BIOPSY NEEDLE | Manan Medical Products, Inc. | 1990-09-05 |
| K901995 | PLEURA BIOPSY DEVICE | Mill-Rose Laboratory | 1990-07-10 |
| K895752 | DIAMOND BLADE SURGICAL KNIVES | Magnum Diamond, Inc. | 1989-10-17 |
Legacy Summary#
summary
FDA Review#
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