Support, Patient Position
FDA product code CCX · Class I (low risk) · 21 CFR 868.6820 · Anesthesiology
8510(k) clearances
0PMA approvals
7recalls
Manufacturers
510(k) clearances
| 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 |
| K801330 | Anspach Leg SupportCCX · Traditional | The Anspach Effort, Inc. | 06/26/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2740-2024 Class II | Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2390-2021 Class II | Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400Affected products were manufactured with materials found to have a bioburden level exceeding the limit at… | Aspen Surgical Products, Inc. | 07/23/2021Terminated |
| Z-2389-2021 Class II | Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601)…Affected products were manufactured with materials found to have a bioburden level exceeding the limit at… | Aspen Surgical Products, Inc. | 07/23/2021Terminated |
| Z-2388-2021 Class II | Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401)…Affected products were manufactured with materials found to have a bioburden level exceeding the limit at… | Aspen Surgical Products, Inc. | 07/23/2021Terminated |
| Z-1997-2014 Class II | Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090…Straps may separate from the foam pad. | Covidien LLC | 05/08/2014Terminated |
| Z-0655-2012 | Allen C-Flex Head Positioning System non-invasive medical device used to support a…C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity | Allen Medical Systems, Inc. | 11/16/2011Terminated |
| Z-1478-2008 | Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a…Handle jamming in the open position, preventing the device from adequately supporting the head during spinal… | Allen Medical Systems, Inc. | 11/27/2007Terminated |