FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAE
K Number: K950170
·
Decision Feb 1, 1995
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
92
Review Days
15
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Basic Information
- Device Name
- CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAE
- K Number
- K950170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Conmedcorp
- Date Received
- January 17, 1995
- Decision Date
- February 1, 1995
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Conmedcorp
| K Number | Device Name | ||
|---|---|---|---|
| K101534 | CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM | Nov 24, 2010 | Substantially Equivalent |
| K061021 | ENTAKE STANDARD AND SAFETY PEG SYSTEM | Apr 28, 2006 | Substantially Equivalent |
| K050992 | CONMED IRRIGATION NOZZLE | Jul 14, 2005 | Substantially Equivalent |
| K050777 | PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 | Apr 22, 2005 | Substantially Equivalent |
| K050304 | FX WIRE ADVANCED MEASUREMENT GUIDEWIRE | Mar 8, 2005 | Substantially Equivalent |
| 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 |
| K020135 | CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120 | Apr 12, 2002 | Substantially Equivalent |
| K020186 | CONMED SYSTEM 5000 ESU | Apr 12, 2002 | Substantially Equivalent |