C.A.S.E. Container
FDA 510(k) K844652 · General Medical Co.
510(k) numberK844652
Submission
- Device name
- C.A.S.E. Container
- Applicant
- General Medical Co.
Washington, DC, US - Received
- November 29, 1984
- Decision date
- December 12, 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 |
|---|---|---|
| K926269 | Procedure KitLRO · Traditional | 08/27/1993SEKD |
| K912975 | Operand Lubricating JellyKMJ · Traditional | 09/27/1991SE |
| K912132 | Operand Lubricating JellyFHX · Traditional | 08/07/1991SE |
| K903669 | Genesis Insufflating CatheterBSY · Traditional | 09/12/1990SE |
| K900110 | Operand* Lubricating JellyKMJ · Traditional | 05/02/1990SE |
| K853635 | Subderm TMEGJ · Traditional | 12/20/1985SE |
| K831320 | DrionicEGJ · Traditional | 07/19/1983SE |
| K820689 | C.S.R. WrappersFRG · Traditional | 04/09/1982SE |
| K820521 | Sterilization WrapFRG · Traditional | 03/18/1982SE |
| K802231 | Air Viva IIBTM · Traditional | 10/10/1980SE |
Questions and answers
When was C.A.S.E. Container cleared by the FDA?
C.A.S.E. Container (K844652) received a 510(k) decision of Substantially Equivalent on December 12, 1984, 13 days after the submission was received.
What is the product code of K844652?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.