TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;
FDA 510(k) clearance K992994 · decided 1999-11-23
Clearance details
- K-number
- K992994
- Device name
- TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;
- Applicant
- Gyrus Ent LLC
- Decision
- Substantially Equivalent
- Date received
- 1999-09-07
- Decision date
- 1999-11-23
- Days to decision
- 77 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
- Bartlett, TN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|
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| Stryker Consolidated Operating Room Equipment (CORE) 2 Console (K171840) | Stryker Corporation | 2017-09-15 |
| 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider (K163247) | Laurimed, LLC | 2017-03-09 |
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Recalls involving this device
No recalls on record reference this clearance.