STRYKER STILETTO ELECTROSURGICAL PROBE
FDA 510(k) clearance K052141 · decided 2005-10-06
Clearance details
- K-number
- K052141
- Device name
- STRYKER STILETTO ELECTROSURGICAL PROBE
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2005-08-08
- Decision date
- 2005-10-06
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551 recall (Z-1704-2011) | Stryker Endoscopy | 2011-03-17 |
| Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, recall (Z-0573-2008) | Stryker Endoscopy | 2008-03-05 |
| Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical Suction recall (Z-0574-2008) | Stryker Endoscopy | 2008-03-05 |