Raylor Mini-Probe
FDA 510(k) K863416 · Cedar Surgical, Inc.
510(k) numberK863416
Submission
- Device name
- Raylor Mini-Probe
- Applicant
- Cedar Surgical, Inc.
Minnetonka, MN, US - Received
- September 3, 1986
- Decision date
- September 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K220920 | Matreneu Percutaneous Balloon Compression KitHAO · Traditional | Shenzhen Shineyard Medical Device Co. , Ltd. | 09/07/2022SE |
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| K951492 | Rib ResectorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 05/18/1995SE |
| K943115 | Auto Suture Pituitary Spinal RongeurHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/25/1994SE |
| K942971 | Auto Suture Spinal DissectorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942970 | Auto Suture Spinal ElevatorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942969 | Auto Suture Spinal Nerve HookHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942968 | Auto Suture Spinal OsteotomeHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942967 | Auto Suture Spinal CuretteHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K923723 | Silicone Brain Spatula SetHAO · Traditional | Redmond Neurosurgical, Inc. | 08/12/1992SE |
More from Redmond Neurosurgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873692 | Raylor(Tm) Drill StopHBE · Traditional | 12/17/1987SE |
| K872281 | Raylor Fusion FunnelHXR · Traditional | 11/02/1987SE |
| K873690 | Cedar(Tm) Pelvic CushionLWG · Traditional | 10/26/1987SE |
| K873691 | Cedar(Tm) Retractor RingGZT · Traditional | 09/28/1987SE |
| K864425 | Raylor(Tm) Dissecting HookGDG · Traditional | 12/12/1986SE |
| K864426 | Raylor(Tm) Depth GaugeHTJ · Traditional | 11/26/1986SE |
| K864424 | Raylor(Tm) Protective RetractorGAD · Traditional | 11/26/1986SE |
| K864421 | Raylor(Tm) Periosteal ElevatorsGEG · Traditional | 11/26/1986SE |
| K864423 | Raylor(Tm) Osteotomes · Traditional | 11/24/1986SE |
| K864422 | Raylor(Tm) MalletHWA · Traditional | 11/24/1986SE |
Questions and answers
When was Raylor Mini-Probe cleared by the FDA?
Raylor Mini-Probe (K863416) received a 510(k) decision of Substantially Equivalent on September 24, 1986, 21 days after the submission was received.
What is the product code of K863416?
The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.