SURGICAL HEAD SUPPORT
FDA 510(k) clearance K861915 · decided 1986-05-30
Clearance details
- K-number
- K861915
- Device name
- SURGICAL HEAD SUPPORT
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-19
- Decision date
- 1986-05-30
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- CCX
- Device class
- 1
- Regulation number
- 868.6820
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHIN UP (K943837) | Edward Carden | 1994-10-14 |
| VILA-COOKE(TM) ANESTHESIA PILLOW (K932305) | Sharn, Inc. | 1993-10-05 |
| SNIFF POSITION PILLOW (K934235) | American Medical Development, Inc. | 1993-10-01 |
| AIR UTERINE DISPLACER-AUD 120 (K833022) | Scientific Sales Intl., Inc. | 1983-10-14 |
| VARI-SUPPORT LOW BACK POSTURE PILLOW (K821838) | Body Therapeutics, Inc. | 1982-07-20 |
| PRENATAL SUPPORT PILLOW (K810035) | Supportech, Inc. | 1981-01-23 |
| ANSPACH LEG SUPPORT (K801330) | The Anspach Effort, Inc. | 1980-06-26 |
Recalls involving this device
No recalls on record reference this clearance.