JRP Wound Spreader
FDA 510(k) K152538 · J.R. Parker, LLC
510(k) numberK152538
Submission
- Device name
- JRP Wound Spreader
- Applicant
- J.R. Parker, LLC
West Chester, PA, US - Received
- September 4, 2015
- Decision date
- April 13, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAD – Retractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K942002 | RetractorGAD · Traditional | Automated Medical Products Corp. | 05/17/1994SE |
Questions and answers
When was JRP Wound Spreader cleared by the FDA?
JRP Wound Spreader (K152538) received a 510(k) decision of Substantially Equivalent on April 13, 2016, 222 days after the submission was received.
What is the product code of K152538?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.