Medco Memory Retractor System
FDA 510(k) K874829 · Medical Equipment Development Co., Inc.
510(k) numberK874829
Submission
- Device name
- Medco Memory Retractor System
- Applicant
- Medical Equipment Development Co., Inc.
Cinnaminson, NJ, US - Received
- November 24, 1987
- Decision date
- March 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp…GZT · Traditional | Thompson Surgical Instruments, Inc. | 05/13/2022SE |
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| 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 |
| K120691 | Brain PortGZT · Traditional | Nico Corporation | 06/05/2012SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K911973 | Linear Accelerator CollimatorIYE · Traditional | 10/15/1992SE |
| K901670 | Gnomos Stereotactic DeviceHAW · Traditional | 07/03/1990SE |
| K895537 | Modified Memory Retractor ArmGZT · Traditional | 09/22/1989SE |
| K893911 | Med-Tech Radiolucent Head Fixation SystemHBL · Traditional | 08/29/1989SE |
| K874833 | Arc Adapter AssemblyHAW · Traditional | 03/03/1988SE |
| K802399 | Model 2500 Pneumatic PercussorBYI · Traditional | 10/23/1980SE |
Questions and answers
When was Medco Memory Retractor System cleared by the FDA?
Medco Memory Retractor System (K874829) received a 510(k) decision of Substantially Equivalent on March 24, 1988, 121 days after the submission was received.
What is the product code of K874829?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.