Raylor(Tm) Protective Retractor
FDA 510(k) K864424 · Cedar Surgical, Inc.
510(k) numberK864424
Submission
- Device name
- Raylor(Tm) Protective Retractor
- Applicant
- Cedar Surgical, Inc.
Minnetonka, MN, US - Received
- November 10, 1986
- Decision date
- November 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAD – Retractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K152538 | JRP Wound SpreaderGAD · Traditional | J.R. Parker, LLC | 04/13/2016SE |
| K151104 | Otelo LLGAD · Traditional | Spineart | 01/06/2016SE |
| K132645 | Thoratrak Mics Retractor System, Rack, BladesGAD · Traditional | Medtronic, Inc. | 10/04/2013SE |
| K071775 | DashGAD · Traditional | Ezsurgical | 08/07/2007SE |
| K050256 | Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional | Apple Medical Corp. | 04/26/2005SE |
| K043602 | Quadrant Retractor SystemGAD · Traditional | Medtronic Sofamor Danek | 02/23/2005SE |
| K001339 | MRI Fastsystem Retractor SystemGAD · Special | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 05/17/2000SE |
| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional | Clarus Medical Systems, Inc. | 08/18/1998SE |
| K963006 | Scion Saphenous Vein Harvesting SystemGAD · Traditional | Scion International, Inc. | 09/20/1996SE |
| K943875 | Villalta RetractorGAD · Traditional | Hct, Inc. | 11/09/1994SE |
More from Hct, 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 |
| 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 |
| K863416 | Raylor Mini-ProbeHAO · Traditional | 09/24/1986SE |
Questions and answers
When was Raylor(Tm) Protective Retractor cleared by the FDA?
Raylor(Tm) Protective Retractor (K864424) received a 510(k) decision of Substantially Equivalent on November 26, 1986, 16 days after the submission was received.
What is the product code of K864424?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.