510(k) K102274
- Device
- ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
- Applicant
- ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES
- 510(k) number
- K102274
- Product code
- GAA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-06-15
- Date received
- 2010-08-11
- 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
- CURTIS RAYMOND
- Address
- 80 Shelton Technology Center Shelton CT US 06484 06484
FDA Registration Numbers#
- 3010291427
- 9614641
- 3001728571
- 1319639
- 3008812560
- 3015225571
- 3014312726
- 8010312
- 3005580113
- 3015060216
- 1417485
- 3013445959
- 3010509633
- 2320767
- 1644312
- 1724474
- 3011642792
- 3005180920
- 2320762
- 8030607
- 3002858762
- 9614033
- 3045853999
- 3044026004
- 9615588
- 3013646600
- 3011707784
- 2529846
- 9614709
- 3004777218
- 3015142721
- 1118193
- 2182979
- 3032327991
- 9611283
- 3006283319
- 3012116434
- 3028956516
- 3015859709
- 3026844237
- 3009513193
- 3010515547
- 3008114965
- 1649518
- 1061927
- 3017509841
- 3011689956
- 1646747
- 2183744
- 3009417901
- 3011088743
- 3014420084
- 3006082230
- 3016096097
- 3022320321
- 3005280205
- 3011137372
- 1721504
- 3007305485
- 3038356900
- 3009756153
- 1320894
- 3007675948
- 3013764800
- 3012421607
- 2521402
- 9611102
- 1054811
- 2029015
- 3013840437
- 3024682301
- 3011210208
- 3009265194
- 1319660
- 3007417132
- 3004468406
- 2030624
- 3017406698
- 8043792
- 3031233007
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 |
| 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 |
| K922614 | TURKEL THORACENTESIS SYSTEM | Symbiosis Corp. | 1992-07-30 |
Legacy Summary#
summary
FDA Review#
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