FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDO-NEEDLE INSTRUMENT
K Number: K936207
·
Decision Jun 16, 1994
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
47
Applicant Total
4
Review Days
169
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Basic Information
- Device Name
- ENDO-NEEDLE INSTRUMENT
- K Number
- K936207
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gerard Medical, Inc.
- Date Received
- December 29, 1993
- Decision Date
- June 16, 1994
- Product Code
- GDM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDM | Needle, Aspiration And Injection, Reusable | FDA class 1 | General, Plastic Surgery |
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