FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONMED TROGARD ELECTRONIC TROCAR SYSTEM
K Number: K954599
·
Decision Nov 27, 1995
Classifications
1
FEI Numbers
378
Registration Numbers
378
Same Product Code
35
Applicant Total
92
Review Days
55
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Basic Information
- Device Name
- CONMED TROGARD ELECTRONIC TROCAR SYSTEM
- K Number
- K954599
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Conmedcorp
- Date Received
- October 3, 1995
- Decision Date
- November 27, 1995
- Product Code
- GEA
- 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 |
|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEA), ordered by most recent decision date.
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DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
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DISPOSABLE YANKAUER SUCTION TUBE
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| K041953 | VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART | Aug 9, 2004 | Substantially Equivalent |
| K021079 | ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX | Jul 1, 2002 | Substantially Equivalent |
| K021299 | CONMED HEATWAVE HAND-CONTROLLED ELETRODE | Jun 26, 2002 | Substantially Equivalent |
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