FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDODYNAMIC SIEGEL SPHINCTEROTOME
K Number: K853680
·
Decision Nov 4, 1985
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
56
Review Days
61
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Basic Information
- Device Name
- ENDODYNAMIC SIEGEL SPHINCTEROTOME
- K Number
- K853680
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- E-Z-Em, Inc.
- Date Received
- September 4, 1985
- Decision Date
- November 4, 1985
- Product Code
- KNS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNS), ordered by most recent decision date.
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Other Clearances by E-Z-Em, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071378 | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES | Jun 13, 2007 | Substantially Equivalent |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | Apr 13, 2007 | Substantially Equivalent |
| K063029 | EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 | Nov 2, 2006 | Substantially Equivalent |
| K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | Dec 27, 2005 | Substantially Equivalent |
| K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) | Jul 16, 2004 | Substantially Equivalent |
| K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | Jun 19, 2003 | Substantially Equivalent |
| K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 | Apr 16, 2003 | Substantially Equivalent |
| K013219 | PROTOCO2L INSUFFLATOR MODEL 6400 | Feb 19, 2002 | Substantially Equivalent |
| K011160 | E-Z EM PERCUPUMP 2001 CT INJECTOR | May 16, 2001 | Substantially Equivalent |
| K974621 | PERCUPUMP II WITH EDA | Jan 27, 1998 | Substantially Equivalent |