FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE AIRWAY
K Number: K810069
·
Decision Feb 2, 1981
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
15
Review Days
20
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Basic Information
- Device Name
- STERILE AIRWAY
- K Number
- K810069
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medspec Corp.
- Date Received
- January 13, 1981
- Decision Date
- February 2, 1981
- 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
FDA 510(k)
FDA Class 1
·Anesthesiology
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
FDA 510(k)
FDA Class 1
·Anesthesiology
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
·Anesthesiology
CUFFED OROPHARYNGEAL AIRWAY (COPA)
FDA 510(k)
FDA Class 1
·Anesthesiology
RUSCH OPTOSAFE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Medspec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K813012 | STERILE BASIN SETS | Nov 6, 1981 | Substantially Equivalent |
| K812711 | STERILE GAUZE PADS 12PLY | Nov 2, 1981 | Substantially Equivalent |
| K812707 | STERILE DISSECTOR SPONGES-X-RAY DETECT | Nov 2, 1981 | Substantially Equivalent |
| K812710 | STERILE LAPAROTOMY SPONGES-X-RAY DETECT | Nov 2, 1981 | Substantially Equivalent |
| K812709 | STERILE DENTAL ROLL | Oct 23, 1981 | Substantially Equivalent |
| K810071 | STERILE SILICONE TUBING | Feb 12, 1981 | Substantially Equivalent |
| K802060 | STERILE TONSIL SPONGES | Oct 10, 1980 | Substantially Equivalent |
| K801069 | STERILE ISOLATION GOWN | May 20, 1980 | Substantially Equivalent |
| K801068 | STERILE ABDOMINAL PAD | May 20, 1980 | Substantially Equivalent |
| K800278 | MEDSPEC SAFETY PINS | May 2, 1980 | Substantially Equivalent |