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#
- 9617601
- 3009217531
- 3015859709
- 8010312
- 1721504
- 3016426851
- 1320894
- 3013445959
- 3009750712
- 3015176914
- 2433012
- 1220592
- 3008559295
- 3013646600
- 1222168
- 3011050570
- 3007329020
- 3019878714
- 3002808022
- 3006234743
- 3002806603
- 3008280196
- 3004962788
- 3012116434
- 1211566
- 3010515547
- 3035708926
- 2530154
- 3018094310
- 3002858762
- 1043214
- 3005853033
- 1000614268
- 1450392
- 3011280379
- 1530671
- 1061927
- 3004496829
- 3008808560
- 3017210006
- 3005987240
- 3017406698
- 3004605493
- 3008583793
- 1720929
- 3005405146
- 2084346
- 1423662
- 3004111573
- 2529846
- 3017538679
- 3014312726
- 8043396
- 1036781
- 3028956516
- 1319660
- 3005580113
- 3008828237
- 3009211636
- 3014200871
- 3015060216
- 1118193
- 3012478173
- 1211998
- 1064858
- 3004749705
- 3004551550
- 3015219237
- 3029952419
- 1056553
- 3008132398
- 3006082230
- 9617744
- 3005034064
- 1048735
- 3026844237
- 3003637761
- 3009702671
- 3013466775
- 3013764800
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases