Villalta Retractor
FDA 510(k) K943875 · Hct, Inc.
510(k) numberK943875
Submission
- Device name
- Villalta Retractor
- Applicant
- Hct, Inc.
Indianapolis, IN, US - Received
- August 8, 1994
- Decision date
- November 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| 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 |
| K942002 | RetractorGAD · Traditional | Automated Medical Products Corp. | 05/17/1994SE |
Questions and answers
When was Villalta Retractor cleared by the FDA?
Villalta Retractor (K943875) received a 510(k) decision of Substantially Equivalent on November 9, 1994, 93 days after the submission was received.
What is the product code of K943875?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.