Quadrant Retractor System
FDA 510(k) K043602 · Medtronic Sofamor Danek
510(k) numberK043602
Submission
- Device name
- Quadrant Retractor System
- Applicant
- Medtronic Sofamor Danek
Memphis, TN, US - Received
- December 29, 2004
- Decision date
- February 23, 2005
- 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
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| K152538 | JRP Wound SpreaderGAD · Traditional | J.R. Parker, LLC | 04/13/2016SE |
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| K963006 | Scion Saphenous Vein Harvesting SystemGAD · Traditional | Scion International, Inc. | 09/20/1996SE |
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| K942002 | RetractorGAD · Traditional | Automated Medical Products Corp. | 05/17/1994SE |
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Questions and answers
When was Quadrant Retractor System cleared by the FDA?
Quadrant Retractor System (K043602) received a 510(k) decision of Substantially Equivalent on February 23, 2005, 56 days after the submission was received.
What is the product code of K043602?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.