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#
- 3005580113
- 3019555526
- 9614279
- 3032327991
- 1828424
- 1319639
- 3031233007
- 3011088743
- 1921846
- 3015077548
- 3008828237
- 9617616
- 1221051
- 1423537
- 3038294399
- 3005675811
- 9680794
- 3007017524
- 3015142721
- 2084346
- 3003418325
- 3005987240
- 1217831
- 8030607
- 3026844237
- 3043531632
- 3007344957
- 3002808022
- 3008280196
- 3030626857
- 1061124
- 3006950086
- 3015859709
- 3035386166
- 3017406698
- 9616088
- 3004111573
- 1036781
- 3004777218
- 3015042030
- 3003637761
- 1929756
- 1222168
- 3035642068
- 9614641
- 3015831087
- 1530671
- 3010071016
- 2183319
- 3012536737
- 9611102
- 1720929
- 3007597038
- 1526534
- 3038356900
- 1064371
- 3012494290
- 3008808560
- 3017210006
- 3005853033
- 2030624
- 3013557562
- 1047843
- 3030446844
- 3012037425
- 3007895168
- 3004608878
- 1056553
- 3027617478
- 1064005
- 3027329031
- 3008110533
- 3007675948
- 2320762
- 3014408997
- 2028661
- 3010392991
- 3010515547
- 3014761220
- 1320894
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 |
| K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | Manan Medical Products, Inc. | 1994-02-25 |
| K940025 | MANAN BONE MARROW HARVEST NEEDLES | 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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