Abdominal Paracentesis Tray
FDA 510(k) K842009 · Jayco Pharmaceuticals
510(k) numberK842009
Submission
- Device name
- Abdominal Paracentesis Tray
- Applicant
- Jayco Pharmaceuticals
Camp Hill, PA, US - Received
- May 17, 1984
- Decision date
- October 23, 1984
- 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 |
|---|---|---|
| K844691 | Endoscopic Aspiration Catheter SetOCX · Traditional | 01/02/1985SE |
| K844690 | Endoscopic Multiple Biopsy InstrumentFCL · Traditional | 01/02/1985SE |
| K844689 | Endoscopic Manual Air InsufflatorFCX · Traditional | 01/02/1985SE |
| K842001 | Liver Biopsy Tray · Traditional | 10/15/1984SE |
| K841258 | Foreign Body ProtectorFED · Traditional | 07/09/1984SE |
| K840800 | Polyp-Saver SleveOCZ · Traditional | 03/23/1984SE |
| K830781 | Endo-GuardFOG · Traditional | 03/31/1983SE |
| K810875 | Fecal Staining KitKKJ · Traditional | 05/01/1981SE |
Questions and answers
When was Abdominal Paracentesis Tray cleared by the FDA?
Abdominal Paracentesis Tray (K842009) received a 510(k) decision of Substantially Equivalent on October 23, 1984, 159 days after the submission was received.
What is the product code of K842009?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.