Surgical Head Support
FDA 510(k) K861915 · Treace Medical, Inc.
510(k) numberK861915
Submission
- Device name
- Surgical Head Support
- Applicant
- Treace Medical, Inc.
Memphis, TN, US - Received
- May 19, 1986
- Decision date
- May 30, 1986
- 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 |
| 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 |
More from The Anspach Effort, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883727 | Bucket Prosthesis PorpETB · Traditional | 01/13/1989SE |
| K882349 | Mallet, SurgicalHXL · Traditional | 06/23/1988SE |
| K874779 | Bipolator 50GEI · Traditional | 01/29/1988SE |
| K873154 | Treace Magnum Oto-Tool SystemERL · Traditional | 09/04/1987SE |
| K872000 | Eye GardHOY · Traditional | 07/21/1987SE |
| K870765 | Cannulated Instrument CleanersEKW · Traditional | 05/27/1987SE |
| K871706 | Optha PrepHMT · Traditional | 05/18/1987SE |
| K870759 | Cleaning Solution, Catalog No. 8203LRJ · Traditional | 05/07/1987SE |
| K870766 | Prosthesis WireETB · Traditional | 04/15/1987SE |
| K870764 | Schuknecht Wire Cutting Scissors · Traditional | 03/18/1987SE |
Questions and answers
When was Surgical Head Support cleared by the FDA?
Surgical Head Support (K861915) received a 510(k) decision of Substantially Equivalent on May 30, 1986, 11 days after the submission was received.
What is the product code of K861915?
The FDA product code is CCX – Support, Patient Position, a Class I (low risk) device regulated under 21 CFR 868.6820.