FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
K Number: K080946
·
Decision May 20, 2008
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
180
Applicant Total
2
Review Days
47
Basic Information
- Device Name
- CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
- K Number
- K080946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CONMED ENDOSCOPIC TECHNOLOGIES, INC.
- Date Received
- April 3, 2008
- Decision Date
- May 20, 2008
- Product Code
- KNS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by CONMED ENDOSCOPIC TECHNOLOGIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K091355 | DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 | Jul 22, 2009 | Substantially Equivalent |