Self-Retaining Retractor for Neurosurgery
FDA 510(k) K874956 · Solway, Inc.
510(k) numberK874956
Submission
- Device name
- Self-Retaining Retractor for Neurosurgery
- Applicant
- Solway, Inc.
Hollywood, FL, US - Received
- December 2, 1987
- Decision date
- January 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K180610 | Geister retractor for neuro - and spine surgeryGZT · Traditional | Geister Medizin Technik GmbH | 08/29/2018SE |
| K172433 | NICO BrainPathGZT · Special | Nico Corporation | 09/07/2017SE |
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| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding…GZT · Traditional | Tedan Surgical Innovations, LLC | 03/20/2017SE |
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| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookGZT · Traditional | Nico Corporation | 06/12/2015SE |
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More from Nico Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K874960 | Cardiovascular Surgical InstrumentsDWS · Traditional | 02/05/1988SE |
| K874962 | Forceps Cliprack Ventricular Cannula Saws SpatulasHAO · Traditional | 02/02/1988SE |
| K874964 | Dental Hand InstrumentsEKJ · Traditional | 01/27/1988SE |
| K875043 | Rongeur (Neurosurgical Instruments)HAE · Traditional | 01/22/1988SE |
| K874966 | Tuning ForksGWX · Traditional | 01/04/1988SE |
| K874965 | Manual Surgical Instruments for General UseHTD · Traditional | 12/30/1987SE |
| K874961 | Bone Cutting Instruments & AccessoriesGDR · Traditional | 12/30/1987SE |
| K874959 | Vascular ClampHXD · Traditional | 12/30/1987SE |
| K874954 | Manual RongeurHTX · Traditional | 12/30/1987SE |
| K874952 | Manual Cranial Drill, Burr, Trephine & AccessoriesHBG · Traditional | 12/30/1987SE |
Questions and answers
When was Self-Retaining Retractor for Neurosurgery cleared by the FDA?
Self-Retaining Retractor for Neurosurgery (K874956) received a 510(k) decision of Substantially Equivalent on January 28, 1988, 57 days after the submission was received.
What is the product code of K874956?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.