Clarus Endoscopic Discectomy System Sitetrac Model 6000
FDA 510(k) K980588 · Clarus Medical Systems, Inc.
510(k) numberK980588
Submission
- Device name
- Clarus Endoscopic Discectomy System Sitetrac Model 6000
- Applicant
- Clarus Medical Systems, Inc.
Minneapolis, MN, US - Received
- February 17, 1998
- Decision date
- August 18, 1998
- 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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| K963006 | Scion Saphenous Vein Harvesting SystemGAD · Traditional | Scion International, Inc. | 09/20/1996SE |
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More from Automated Medical Products Corp.
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|---|---|---|
| K974579 | Percscope Model 2600HRX · Traditional | 02/18/1998SE |
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| K971455 | Clarus Model 5197 SightliteFTI · Traditional | 05/20/1997SE |
| K960915 | Clarus Neuropen Endoscopic Placement Kit Model 2125-XXXGWG · Traditional | 12/24/1996SE |
| K962255 | Clarus Murphypen ENDOSCOPE(2127-XXX)EOB · Traditional | 09/11/1996SE |
| K955598 | Clarus Spinepen Model 2126GWG · Traditional | 02/06/1996SE |
| K953685 | Instrument ScopeGWG · Traditional | 10/12/1995SE |
| K945633 | Neuro Channel Endoscope Model 2232GWG · Traditional | 09/19/1995SE |
| K945296 | Clarus Phoenix Neuro Endoscope Model 2160GWG · Traditional | 07/14/1995SE |
| K941188 | Clarus Neuro Endoscope (Model 2230)HRX · Traditional | 04/25/1995SE |
Questions and answers
When was Clarus Endoscopic Discectomy System Sitetrac Model 6000 cleared by the FDA?
Clarus Endoscopic Discectomy System Sitetrac Model 6000 (K980588) received a 510(k) decision of Substantially Equivalent on August 18, 1998, 182 days after the submission was received.
What is the product code of K980588?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.