FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETHICON ENDO-SURGERYOPTICAL DILATOR
K Number: K093236
·
Decision Nov 10, 2009
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
39
Applicant Total
111
Review Days
26
Basic Information
- Device Name
- ETHICON ENDO-SURGERYOPTICAL DILATOR
- K Number
- K093236
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ETHICON ENDO-SURGERY, INC.
- Date Received
- October 15, 2009
- Decision Date
- November 10, 2009
- Product Code
- KNQ
- 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 |
|---|---|---|---|
| KNQ | Dilator, Esophageal | FDA class 2 | Gastroenterology, Urology |
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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 |
| K091290 | ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 | Oct 29, 2009 | Substantially Equivalent |
| K091322 | CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G | Jun 1, 2009 | Substantially Equivalent |