FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDO SMARTCAP
K Number: K093665
·
Decision Dec 15, 2009
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
91
Applicant Total
12
Review Days
20
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Basic Information
- Device Name
- ENDO SMARTCAP
- K Number
- K093665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Byrne Medical, Inc.
- Date Received
- November 25, 2009
- Decision Date
- December 15, 2009
- Product Code
- FAJ
- 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 |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAJ), ordered by most recent decision date.
OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,
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Other Clearances by Byrne Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR | Jun 20, 2012 | Substantially Equivalent |
| K113119 | ENDOGATOR ADVANTAGE IRRIGATION PUMP | Apr 27, 2012 | Substantially Equivalent |
| K102855 | UNIVERSAL IRRIGATION SOLUTION HYBRID | Nov 19, 2010 | Substantially Equivalent |
| K102581 | DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 | Nov 8, 2010 | Substantially Equivalent |
| K102409 | DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 | Nov 4, 2010 | Substantially Equivalent |
| K092090 | ERBELIFT HAND PUMP AND FLEXIBLE PROBE | Nov 30, 2009 | Substantially Equivalent |
| K092429 | ENDOGATOR | Nov 19, 2009 | Substantially Equivalent |
| K090851 | DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) | Jul 2, 2009 | Substantially Equivalent |
| K060962 | ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 | Apr 19, 2006 | Substantially Equivalent |
| K033695 | IRRIGATION CHANNEL TUBING, MODEL 100135 | Dec 23, 2003 | Substantially Equivalent |