FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDOPATH TISSUE RETAINING COMPONENT
K Number: K923679
·
Decision Sep 9, 1992
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
3
Applicant Total
111
Review Days
49
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Basic Information
- Device Name
- ENDOPATH TISSUE RETAINING COMPONENT
- K Number
- K923679
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5220
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ethicon Endo-Surgery, Inc.
- Date Received
- July 22, 1992
- Decision Date
- September 9, 1992
- Product Code
- KCJ
- 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 |
|---|---|---|---|
| KCJ | Applicator, Ent | FDA class 1 | Ear, Nose, Throat |
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