FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORAL AIRWAY
K Number: K891586
·
Decision May 11, 1989
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
19
Review Days
52
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Basic Information
- Device Name
- ORAL AIRWAY
- K Number
- K891586
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dynarex Corp.
- Date Received
- March 20, 1989
- Decision Date
- May 11, 1989
- Product Code
- CAE
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAE), ordered by most recent decision date.
LMA FAMILY OF AIRWAYS
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FDA Class 1
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KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
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KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
FDA 510(k)
FDA Class 1
·Anesthesiology
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
FDA 510(k)
FDA Class 1
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CUFFED OROPHARYNGEAL AIRWAY (COPA)
FDA 510(k)
FDA Class 1
·Anesthesiology
RUSCH OPTOSAFE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Dynarex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | Dec 22, 2005 | Substantially Equivalent |
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE | Nov 9, 2005 | Substantially Equivalent |
| K012816 | DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 | Oct 17, 2002 | Substantially Equivalent |
| K012957 | TOWEL DRAPE, MODELS 4409, 4410 | Mar 6, 2002 | Substantially Equivalent |
| K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | Nov 28, 2001 | Substantially Equivalent |
| K991695 | DYNAREX NON-WOVEN SPONGE | Jul 15, 1999 | Substantially Equivalent |
| K991694 | DYNAREX DRAIN SPONGE | Jul 15, 1999 | Substantially Equivalent |
| K983348 | DYNAREX TRACHEOSTOMY SPONGE | Dec 11, 1998 | Substantially Equivalent |
| K960388 | DYNAREX NON-WOVEN SPONGE | Apr 1, 1996 | Substantially Equivalent |
| K951660 | DYNAREX GAUZE SPONGE | May 9, 1995 | Substantially Equivalent |