FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIONEER ELEC-TROCAR DEVICE
K Number: K971728
·
Decision Sep 19, 1997
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
50
Review Days
133
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Basic Information
- Device Name
- PIONEER ELEC-TROCAR DEVICE
- K Number
- K971728
- 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
- Pioneer Surgical Technology
- Date Received
- May 9, 1997
- Decision Date
- September 19, 1997
- 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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| K093771 | QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM | Aug 10, 2010 | Substantially Equivalent |
| K100708 | PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES | Jun 4, 2010 | Substantially Equivalent |
| K100361 | NANOSS BONE VOID FILLER | Apr 22, 2010 | Substantially Equivalent |
| K092295 | PIONEER POSTERIOR CERVICO-THORACIC SYSTEM | Feb 19, 2010 | Substantially Equivalent |
| K091031 | PIONEER SURGICAL NANOSS BVF-E | Nov 17, 2009 | Substantially Equivalent |
| K083449 | E-MATRIX GRAFT BONE EXTENDER | Jun 12, 2009 | Substantially Equivalent |