Chemonucleolysis/Discography Tray
FDA 510(k) K840334 · Applied Medical Devices, Inc.
510(k) numberK840334
Submission
- Device name
- Chemonucleolysis/Discography Tray
- Applicant
- Applied Medical Devices, Inc.
Mchenry, IL, US - Received
- January 25, 1984
- Decision date
- April 13, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
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|---|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K843885 | Percutaneous Aspiration Biopsy Tray · Traditional | 12/19/1984SE |
| K843884 | General Utility Tray System · Traditional | 12/13/1984SE |
| K843883 | Sterile Percutaneous Transhepatic Cholan · Traditional | 12/13/1984SE |
| K840904 | Accu-Cult Fecal Occult Blood TestKHE · Traditional | 08/16/1984SE |
| K842591 | Ultrasound Probe Covers-SterileIYO · Traditional | 07/23/1984SE |
| K833720 | Transthoracic/Transabdominal-TrayGDM · Traditional | 05/30/1984SE |
| K833438 | Prepacell-Sterile-Bone Marrow AspirKDD · Traditional | 02/09/1984SE |
| K833719 | Prepacell Thin Needle Aspiration TrayKOD · Traditional | 01/25/1984SE |
| K802406 | Cytotran I Bone Marrow Aspiration SystemFMF · Traditional | 01/15/1981SE |
| K791660 | Prepacell-Bone Marrow SamplerFMF · Traditional | 09/12/1979SE |
Questions and answers
When was Chemonucleolysis/Discography Tray cleared by the FDA?
Chemonucleolysis/Discography Tray (K840334) received a 510(k) decision of Substantially Equivalent on April 13, 1984, 79 days after the submission was received.
What is the product code of K840334?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.