FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-T AIR DRILL
K Number: K905800
·
Decision Apr 22, 1991
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
90
Applicant Total
12
Review Days
115
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Basic Information
- Device Name
- X-T AIR DRILL
- K Number
- K905800
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4250
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Xomed-Treace, Inc.
- Date Received
- December 28, 1990
- Decision Date
- April 22, 1991
- Product Code
- ERL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
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Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
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Other Clearances by Xomed-Treace, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940028 | ENDOSCOPE SHEATH | Mar 24, 1995 | Substantially Equivalent |
| K941407 | TYMPANOSTOMY (VENTILATION) TUBE | Mar 14, 1995 | Substantially Equivalent |
| K945659 | BLACKSTAR(TM) STAR SYSTEM | Jan 9, 1995 | Substantially Equivalent |
| K932771 | BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE | Aug 24, 1994 | Substantially Equivalent |
| K933672 | XOMED-TREACE SCOPESHEATH | Jul 18, 1994 | Substantially Equivalent |
| K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) | May 13, 1994 | Substantially Equivalent |
| K933105 | XOMED-TREACE RIGID ROD LENS ENDOSCOPE | Jan 5, 1994 | Substantially Equivalent |
| K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN | Aug 17, 1993 | Substantially Equivalent |
| K922880 | XOMED TREACE JET VENTILATION TUBE | Apr 15, 1993 | Substantially Equivalent |
| K923830 | XOMED-TREACE ALPHASCOPE | Nov 9, 1992 | Substantially Equivalent |