Anspach Leg Support
FDA 510(k) K801330 · The Anspach Effort, Inc.
510(k) numberK801330
Submission
- Device name
- Anspach Leg Support
- Applicant
- The Anspach Effort, Inc.
Mchenry, IL, US - Received
- June 3, 1980
- Decision date
- June 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCX – Support, Patient Position
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6820
- Specialty
- Anesthesiology
Other 510(k)s with product code CCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943837 | Chin UpCCX · Traditional | Edward Carden | 10/14/1994SE |
| K932305 | Vila-Cooke(Tm) Anesthesia PillowCCX · Traditional | Sharn, Inc. | 10/05/1993SE |
| K934235 | Sniff Position PillowCCX · Traditional | American Medical Development, Inc. | 10/01/1993SE |
| K861915 | Surgical Head SupportCCX · Traditional | Treace Medical, Inc. | 05/30/1986SE |
| K833022 | Air Uterine Displacer-Aud 120CCX · Traditional | Scientific Sales Intl., Inc. | 10/14/1983SE |
| K821838 | Vari-Support Low Back Posture PillowCCX · Traditional | Body Therapeutics, Inc. | 07/20/1982SE |
| K810035 | Prenatal Support PillowCCX · Traditional | Supportech, Inc. | 01/23/1981SE |
More from Supportech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A…HBC · Traditional | 05/19/2022SE |
| 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 |
| K063688 | Surgical Irrigation System, Irrigation TubeHWE · Special | 01/16/2007SE |
Questions and answers
When was Anspach Leg Support cleared by the FDA?
Anspach Leg Support (K801330) received a 510(k) decision of Substantially Equivalent on June 26, 1980, 23 days after the submission was received.
What is the product code of K801330?
The FDA product code is CCX – Support, Patient Position, a Class I (low risk) device regulated under 21 CFR 868.6820.