Surgical Irrigation System, Irrigation Tube
FDA 510(k) K063688 · The Anspach Effort, Inc.
510(k) numberK063688
Submission
- Device name
- Surgical Irrigation System, Irrigation Tube
- Applicant
- The Anspach Effort, Inc.
Palm Beach Gardens, FL, US - Received
- December 12, 2006
- Decision date
- January 16, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K990816 | Avcore SystemHWE · Traditional | Modular Cutting Systems, Inc. | 09/24/1999SE |
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| K183545 | Anspach Helix Dissection ToolsHBE · Traditional | 07/19/2019SE |
| K180063 | OCM-G1 AttachmentERL · Special | 03/27/2018SE |
| K133604 | Anspach EG1 High Speed System, G1 AttachmentsHBC · Special | 01/10/2014SE |
| K131053 | Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemERL · Traditional | 12/31/2013SE |
| K113476 | Anspach Dissection ToolsHBE · Special | 12/16/2011SE |
| K082637 | Cranial PerforatorHBF · Traditional | 12/22/2008SE |
| K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP…HBE · Special | 04/30/2008SE |
| K061297 | Anspach Imri Safe Surgical Drill SystemHBB · Traditional | 01/26/2007SE |
| K052572 | Anspach Knotless AnchorMBI · Traditional | 12/05/2005SE |
Questions and answers
When was Surgical Irrigation System, Irrigation Tube cleared by the FDA?
Surgical Irrigation System, Irrigation Tube (K063688) received a 510(k) decision of Substantially Equivalent on January 16, 2007, 35 days after the submission was received.
What is the product code of K063688?
The FDA product code is HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.