FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEIGER NEEDLE ADAPTER, MODEL 406
K Number: K001029
·
Decision May 23, 2000
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
5
Review Days
54
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Basic Information
- Device Name
- GEIGER NEEDLE ADAPTER, MODEL 406
- K Number
- K001029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Geiger Medical Technologies, Inc.
- Date Received
- March 30, 2000
- Decision Date
- May 23, 2000
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Geiger Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002341 | THERMAL CAUTERY UNIT, MODEL 150 | Oct 23, 2000 | Substantially Equivalent |
| K994075 | GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435 | Dec 27, 1999 | Substantially Equivalent |
| K992149 | GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405 | Aug 19, 1999 | Substantially Equivalent |
| K983852 | BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429 | Jan 28, 1999 | Substantially Equivalent |