510(k) K962425
- Device
- BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
- Applicant
- RADI MEDICAL SYSTEMS AB
- 510(k) number
- K962425
- Product code
- GAA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-11
- Date received
- 1996-06-24
- Regulation
- 878.4800
- Classification name
- Needle, Aspiration And Injection, Disposable
- 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
- PER EGNELOV
- Address
- Palmbladsgatan 10 Uppsala SE S-754 50 S-754 50
FDA Registration Numbers#
- 3004468406
- 9617601
- 1423537
- 3013576619
- 1000632857
- 1024879
- 3019012929
- 3003674698
- 3011642792
- 3043007473
- 3003637761
- 9611446
- 2320767
- 3008110533
- 1047843
- 2433012
- 3013633270
- 1835568
- 1054241
- 3014420084
- 3010097171
- 3027329031
- 1220477
- 3008583793
- 3015176914
- 3014570560
- 3009417901
- 9617616
- 3007597038
- 2243072
- 3007344957
- 3015831087
- 2126670
- 2084346
- 9680620
- 3009337401
- 1820334
- 1213809
- 2083373
- 1417485
- 1061124
- 3014769442
- 1926681
- 3017509841
- 1017768
- 3030733800
- 3016904853
- 2320762
- 3005675811
- 3004215117
- 3038294399
- 1054811
- 3015745029
- 3002808022
- 3009217531
- 1424263
- 8010312
- 3015219237
- 3008436219
- 3008559295
- 3007225376
- 2183319
- 2032098
- 3019555526
- 3002858762
- 3004464325
- 3007675948
- 3013445959
- 3030447506
- 8021538
- 3016096097
- 3006638830
- 3005987240
- 3013646600
- 3014579161
- 3026844237
- 1319660
- 3004168759
- 3011210208
Source Documents#
Other 510(k) Records For Product Code GAA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223625 | CapnoSpot™ Pneumothorax Decompression Indicator | Pneumeric, Inc. | 2023-03-28 |
| K102274 | ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT | Arvik Enterprises/ Mini Lap Technologies | 2011-06-15 |
| K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | Diametrics Medical, Inc. | 2001-11-16 |
| K994151 | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES | Ximed/Prosure/Injectx | 2000-03-01 |
| K983200 | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX | Ximed/Prosure/Injectx | 1998-12-11 |
| K974741 | MANAN ACCURA NEEDLE | Medical Device Technologies, Inc. | 1998-01-08 |
| K961959 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | Medical Device Technologies, Inc. | 1996-07-19 |
| K945109 | MONOJECT BONE MARROW BIOPSY TRAYS | Sherwood Medical Co. | 1994-11-14 |
| K940025 | MANAN BONE MARROW HARVEST NEEDLES | Manan Medical Products, Inc. | 1994-02-25 |
| K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | Manan Medical Products, Inc. | 1994-02-25 |
| K930158 | BONE MARROW BIOPSY PROCEDURE TRAY | Symbiosis Corp. | 1993-07-02 |
| K925621 | IRRIGATION/ASPIRATION TUBING SET | Kirwan Surgical Products, Inc. | 1993-05-07 |
| K924501 | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | 1993-04-20 |
| K925416 | SYMBIOSIS BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | 1993-02-23 |
| K922614 | TURKEL THORACENTESIS SYSTEM | Symbiosis Corp. | 1992-07-30 |
Legacy Summary#
summary
FDA Review#
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