510(k) K813448
- Device
- POTTS-COURNAND STYLE NEEDLE
- Applicant
- OCEAN MEDICAL PRODUCTS, LTD.
- 510(k) number
- K813448
- Product code
- GAA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-01-07
- Date received
- 1981-12-11
- 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
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014570560
- 3007527549
- 3007017524
- 3005676736
- 3011707784
- 1320894
- 3005987240
- 1828424
- 3006950086
- 3011137372
- 3023316
- 1721686
- 3023809973
- 3004748528
- 3009217531
- 3007597038
- 3015042030
- 3034676720
- 3003310007
- 1045254
- 3013633270
- 3009756153
- 3011280379
- 3017538679
- 3004777218
- 3013646600
- 3005034064
- 1721504
- 3005280205
- 3043226252
- 9611102
- 3007895168
- 3014021001
- 1064371
- 3008571754
- 1820334
- 2320762
- 9615588
- 1720929
- 3002858762
- 3013764800
- 3044026004
- 3004468406
- 3043007473
- 3000247873
- 3017636737
- 1423537
- 1450662
- 3004111573
- 1055236
- 3004749705
- 3030447506
- 2011171
- 3012494290
- 8043792
- 3007305485
- 3014769442
- 3008280196
- 1061124
- 3012267976
- 1417592
- 1319660
- 3010291427
- 3014200871
- 9680794
- 3005670221
- 3012037425
- 3012448339
- 3030078769
- 3010509633
- 1048735
- 3010071016
- 3015225571
- 2523676
- 3011689956
- 3038356900
- 2029275
- 3005083075
- 3047841122
- 3009513193
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#
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