Adt Bone Mar. Bio/Asp. Tray W/Needle
FDA 510(k) K800408 · A.D.T. Lab Industries
510(k) numberK800408
Submission
- Device name
- Adt Bone Mar. Bio/Asp. Tray W/Needle
- Applicant
- A.D.T. Lab Industries
Mchenry, IL, US - Received
- February 26, 1980
- Decision date
- April 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K223625 | CapnoSpot Pneumothorax Decompression IndicatorGAA · Traditional | Pneumeric, Inc. | 03/28/2023SE |
| K102274 | Arvik Laparoscopic Aspiration InstrumentGAA · Traditional | Arvik Enterprises/ Mini Lap Technologies | 06/15/2011SE |
| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
| K994151 | Percutx-Injection/Aspiration Needle Probes/DevicesGAA · Traditional | Ximed/Prosure/Injectx | 03/01/2000SE |
| K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexGAA · Traditional | Ximed/Prosure/Injectx | 12/11/1998SE |
| K974741 | Manan Accura NeedleGAA · Traditional | Medical Device Technologies, Inc. | 01/08/1998SE |
| K962425 | Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional | Radi Medical Systems AB | 09/11/1996SE |
| K961959 | MD Tech Biopsy Set for Bone and Bone MarrowGAA · Traditional | Medical Device Technologies, Inc. | 07/19/1996SE |
| K945109 | Monoject Bone Marrow Biopsy TraysGAA · Traditional | Sherwood Medical Co. | 11/14/1994SE |
| K940025 | Manan Bone Marrow Harvest NeedlesGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K812297 | A.D.T. Procedures TrayKMJ · Traditional | 09/28/1981SE |
| K801754 | Adt Bone Marrow Aspiration NeedleGAA · Traditional | 08/20/1980SE |
| K801753 | Adt Bone Marrow Biopsy-Aspir. NeeldeGAA · Traditional | 08/20/1980SE |
| K800418 | Adt Disposable Thin Needle AspirationFSM · Traditional | 04/28/1980SE |
| K800417 | Adt PTC Pro. Tray W/(Skinny Chiba) NeedlGAA · Traditional | 04/28/1980SE |
| K800414 | Adt Soft Tissue Biopsy TrayGAA · Traditional | 04/28/1980SE |
| K800412 | Rosenthal Needle (Disp.) Adt Bone MarrowGAA · Traditional | 04/28/1980SE |
| K800411 | Aspiration Tray W/Ferris Disp. IllinoisGAA · Traditional | 04/28/1980SE |
| K800410 | Adt Bone Marrow Biopsy-Aspiration TrayGAA · Traditional | 04/28/1980SE |
| K800409 | Adt Bone Marrow Biopsy Aspiration TrayGAA · Traditional | 04/28/1980SE |
Questions and answers
When was Adt Bone Mar. Bio/Asp. Tray W/Needle cleared by the FDA?
Adt Bone Mar. Bio/Asp. Tray W/Needle (K800408) received a 510(k) decision of Substantially Equivalent on April 28, 1980, 62 days after the submission was received.
What is the product code of K800408?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.