Adt Disposable Thin Needle Aspiration
FDA 510(k) K800418 · A.D.T. Lab Industries
510(k) numberK800418
Submission
- Device name
- Adt Disposable Thin Needle Aspiration
- 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
- FSM – Tray, Surgical, Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971217 | Instrument Tray LinerFSM · Traditional | General Hospital Supply Corp. | 05/06/1997SE |
| K962328 | Single Use Instrument TrayFSM · Traditional | Medcare Medical Group, Inc. | 08/09/1996SE |
| K944025 | Surgical Instrument TrayFSM · Traditional | Riley Medical, Inc. | 11/22/1994SE |
| K912106 | Arthroscopy TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/29/1991SE |
| K912053 | Open Heart TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/26/1991SE |
| K912052 | Heart Cath TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/20/1991SE |
| K912104 | Major Basin TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/09/1991SE |
| K910570 | Splinter TweezersFSM · Traditional | Solan Scissors Sales | 05/31/1991SE |
| K911601 | Reddick Trocar and CannulaFSM · Traditional | Ideal Medical, Inc. | 05/21/1991SE |
| K910328 | Key Comfort GripsFSM · Traditional | Key Surgical, Inc. | 03/06/1991SE |
More from Key Surgical, 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 |
| 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 |
| K800408 | Adt Bone Mar. Bio/Asp. Tray W/NeedleGAA · Traditional | 04/28/1980SE |
Questions and answers
When was Adt Disposable Thin Needle Aspiration cleared by the FDA?
Adt Disposable Thin Needle Aspiration (K800418) 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 K800418?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.