RAYLOR MINI-PROBE
FDA 510(k) clearance K863416 · decided 1986-09-24
Clearance details
- K-number
- K863416
- Device name
- RAYLOR MINI-PROBE
- Applicant
- Cedar Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-03
- Decision date
- 1986-09-24
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- HAO
- Device class
- 1
- Regulation number
- 882.4535
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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| AUTO SUTURE PITUITARY SPINAL RONGEUR (K943115) | United States Surgical, A Division of Tyco Healthc | 1994-07-25 |
| AUTO SUTURE SPINAL DISSECTOR (K942971) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL CURETTE (K942967) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL ELEVATOR (K942970) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL OSTEOTOME (K942968) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL NERVE HOOK (K942969) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| SILICONE BRAIN SPATULA SET (K923723) | Redmond Neurosurgical, Inc. | 1992-08-12 |
| BONE PAD REMOVER (K910225) | Acra Cut, Inc. | 1991-02-12 |
| DURAL DISSECTORS (K910226) | Acra Cut, Inc. | 1991-02-12 |
Recalls involving this device
No recalls on record reference this clearance.