APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET
FDA 510(k) clearance K961590 · decided 1996-10-08
Clearance details
- K-number
- K961590
- Device name
- APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET
- Applicant
- Linvatec Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-24
- Decision date
- 1996-10-08
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation recall (Z-1681-2013) | Linvatec Corp. dba ConMed Linvatec | 2013-07-10 |