FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432
K Number: K073484
·
Decision Mar 10, 2008
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
67
Applicant Total
111
Review Days
90
Basic Information
- Device Name
- ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432
- K Number
- K073484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ETHICON ENDO-SURGERY, INC.
- Date Received
- December 11, 2007
- Decision Date
- March 10, 2008
- Product Code
- ODC
- 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 |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODC), ordered by most recent decision date.
Disposable Endoscopy Valve Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Luer-Split MAJ-2092
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Defendo Fujifilm 700 Single Use Cleaning Adapter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Endoscope Valves Set (AF series)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by ETHICON ENDO-SURGERY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K141952 | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED | Nov 24, 2014 | Substantially Equivalent |
| K111195 | VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS | Aug 3, 2011 | Substantially Equivalent |
| K110385 | ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER | Mar 25, 2011 | Substantially Equivalent |
| K101520 | ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH | Dec 10, 2010 | Substantially Equivalent |
| K102632 | ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER | Oct 7, 2010 | Substantially Equivalent |
| K093896 | ETHICON ENDO SURGERY SLOTTED ANOSCOPE | Mar 25, 2010 | Substantially Equivalent |
| K091259 | ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS | Jan 15, 2010 | Substantially Equivalent |
| K091824 | ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 | Nov 27, 2009 | Substantially Equivalent |
| K093236 | ETHICON ENDO-SURGERYOPTICAL DILATOR | Nov 10, 2009 | Substantially Equivalent |
| K091290 | ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 | Oct 29, 2009 | Substantially Equivalent |