510(k) K882105
- Device
- CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM
- Applicant
- DIANON SYSTEMS, INC.
- 510(k) number
- K882105
- Product code
- GAA
- Decision
- Substantially Equivalent - With Drug (SESD)
- Decision date
- 1988-07-11
- Date received
- 1988-05-19
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- PHILLENORE HOWARD
- Address
- 200 Watson Blvd. Stratford CT US 06497 06497
FDA Registration Numbers#
- 3008785630
- 3030446844
- 3006082230
- 2183319
- 3017210006
- 3008114965
- 8030607
- 3008828237
- 3031783617
- 2022435
- 3007225376
- 2953359
- 3045030541
- 1911916
- 3019012929
- 1625425
- 1643817
- 3036722184
- 9680794
- 3013221738
- 3043007473
- 3012478173
- 8043792
- 3029905131
- 8010047
- 3011280379
- 2183744
- 3012448339
- 2320767
- 3007597038
- 1047843
- 3011210208
- 1320894
- 3028956516
- 3015309643
- 3004777218
- 9617616
- 3008571754
- 3005180920
- 3005987240
- 3004468406
- 1066491
- 1450392
- 1213809
- 3008650117
- 1118193
- 2084346
- 3033589330
- 3012421607
- 3008110533
- 9616662
- 1423537
- 2243072
- 1724474
- 2530154
- 3015077548
- 3027329031
- 1036781
- 3001728571
- 3009337401
- 3015745029
- 3011088743
- 1649518
- 2182979
- 3013633270
- 3016096097
- 3017406698
- 9617601
- 3006611221
- 3010097171
- 3005273623
- 2183741
- 3007344957
- 2523676
- 3023274465
- 3006283319
- 1417485
- 3005676736
- 1223925
- 3030626857
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K962425 | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) | Radi Medical Systems AB | 1996-09-11 |
| 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 |
Legacy Summary#
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FDA Review#
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