FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOGRIP
K Number: K926498
·
Decision Apr 7, 1993
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
11
Review Days
99
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Basic Information
- Device Name
- ENDOGRIP
- K Number
- K926498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biomedix, Inc.
- Date Received
- December 29, 1992
- Decision Date
- April 7, 1993
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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