FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE GUEDEL AIRWAY
K Number: K850248
·
Decision Mar 12, 1985
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
32
Review Days
49
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Basic Information
- Device Name
- DISPOSABLE GUEDEL AIRWAY
- K Number
- K850248
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Inmed Corp.
- Date Received
- January 22, 1985
- Decision Date
- March 12, 1985
- 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 Inmed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862672 | ESOPHAGEAL STETHOSCOPE WITH THERMISTOR | Oct 27, 1986 | Substantially Equivalent |
| K853162 | STERILE NASOPHARYNGEAL AIRWAY | Aug 6, 1985 | Substantially Equivalent |
| K850152 | PRECONNECTED URETHRAL CATHETER TRAY | Mar 12, 1985 | Substantially Equivalent |
| K850335 | URETEROSCOPY CATHETER | Mar 12, 1985 | Substantially Equivalent |
| K844801 | ULTRA EXTERNAL CATHETER | Jan 15, 1985 | Substantially Equivalent |
| K842301 | DISPOSABLE LATEX BANDAGE | Nov 5, 1984 | Substantially Equivalent |
| K842866 | URETHRAL CATHETERIZATION TRAY | Sep 10, 1984 | Substantially Equivalent |
| K841040 | FOX POST NASAL BALLOON CATHETER | Aug 17, 1984 | Substantially Equivalent |
| K842865 | ESOPHAGEAL STETHOSCOPE | Aug 15, 1984 | Substantially Equivalent |
| K841037 | PENROSE DRAINS | Apr 25, 1984 | Substantially Equivalent |