510(k) K790142
- Device
- NEEDLE, WITH FILTER
- Applicant
- NATIONAL PATENT DEVELOPMENT CORP.
- 510(k) number
- K790142
- Product code
- GAA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-02-26
- Date received
- 1979-01-19
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3005580113
- 2084346
- 2320762
- 3013421458
- 3015859709
- 3024682301
- 3011088743
- 2020394
- 3006425876
- 3010392991
- 3012116434
- 3045030541
- 9680620
- 3043007473
- 3014456066
- 3014408997
- 3003674698
- 3005034064
- 9616088
- 3035386166
- 3009756153
- 3030626857
- 3031233007
- 1649518
- 3033589330
- 3008785630
- 3003310007
- 9610612
- 3015142721
- 3000247873
- 2032098
- 2243072
- 9617616
- 3007007790
- 3008583793
- 3008559295
- 3009702671
- 3014132286
- 3013840437
- 8040278
- 3007895168
- 3034667025
- 1220592
- 3013557562
- 3003637761
- 3011210208
- 3010097171
- 3006234743
- 2083373
- 3006611221
- 3007597038
- 3007527549
- 3018116884
- 3030446844
- 9680794
- 1828424
- 3005675811
- 1836161
- 2183744
- 9680904
- 3008514120
- 2028661
- 9611283
- 3011137372
- 3023316
- 2433012
- 2022435
- 3010515547
- 3012536737
- 1530671
- 3010291427
- 3013646600
- 3023274465
- 3005676736
- 3010509633
- 3038356900
- 3027617478
- 3012494290
- 3012448339
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#
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
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