Surgical Laser Accessories (Sla) Case
FDA 510(k) K862629 · Simpson/Basye, Inc.
510(k) numberK862629
Submission
- Device name
- Surgical Laser Accessories (Sla) Case
- Applicant
- Simpson/Basye, Inc.
Wilmington, DE, US - Received
- July 10, 1986
- Decision date
- July 17, 1986
- 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 |
|---|---|---|
| K926179 | Sedlacek HandleHGI · Traditional | 03/25/1994SE |
| K891352 | Marlow Anal SpeculumKOA · Traditional | 06/23/1989SE |
| K891351 | Newport Lateral Vaginal RetractorKOH · Traditional | 05/11/1989SE |
| K891350 | Newport Cervical ManipulatorHDC · Traditional | 03/29/1989SE |
| K891349 | Campion Cervical HookHDC · Traditional | 03/29/1989SE |
| K891347 | Reid Endocervical SpreaderHDC · Traditional | 03/29/1989SE |
| K891348 | Campion Laser ForcepsGEN · Traditional | 03/22/1989SE |
| K870276 | Heated Instrument BathLRJ · Traditional | 05/07/1987SE |
| K862717 | Hand Mirror (Endoscope)GCO · Traditional | 07/30/1986SE |
| K790923 | Mi-Mark Endocervical Sampling SetKNA · Traditional | 06/22/1979SE |
Questions and answers
When was Surgical Laser Accessories (Sla) Case cleared by the FDA?
Surgical Laser Accessories (Sla) Case (K862629) received a 510(k) decision of Substantially Equivalent on July 17, 1986, 7 days after the submission was received.
What is the product code of K862629?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.