HUMMER IV MICRODEBRIDER SYSTEM
FDA 510(k) clearance K011381 · decided 2001-05-25
Clearance details
- K-number
- K011381
- Device name
- HUMMER IV MICRODEBRIDER SYSTEM
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 2001-05-07
- Decision date
- 2001-05-25
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- ERL
- Device class
- 2
- Regulation number
- 874.4250
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Instruments
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 |
|---|---|---|
| 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a me recall (Z-1247-2014) | Stryker Instruments Div. of Stryker Corporation | 2014-03-20 |