ARTHROSCOPE ACCESSORIES
FDA 510(k) clearance K944210 · decided 1995-02-14
Clearance details
- K-number
- K944210
- Device name
- ARTHROSCOPE ACCESSORIES
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 1994-08-29
- Decision date
- 1995-02-14
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Endoscopy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Inflow/Outflow Cannula; Qty: 1; distributed by Stryker Endoscopy, 5900 Optical Court, San recall (Z-1927-2011) | Stryker Endoscopy | 2011-04-08 |
| Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, recall (Z-0652-2009) | Stryker Endoscopy | 2009-01-21 |
| Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-07 recall (Z-0868-2009) | Stryker Endoscopy | 2009-01-16 |