FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Endo SmartCap
K Number: K223040
·
Decision Mar 1, 2023
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
91
Applicant Total
11
Review Days
153
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Basic Information
- Device Name
- Endo SmartCap
- K Number
- K223040
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medivators, Inc.
- Date Received
- September 29, 2022
- Decision Date
- March 1, 2023
- Product Code
- FAJ
- 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 |
|---|---|---|---|
| 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 Medivators, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | Jan 14, 2022 | Substantially Equivalent |
| K172677 | Advantage Plus Pass-Thru | Dec 19, 2017 | Substantially Equivalent |
| K162128 | Scope Buddy Plus Endoscope Flushing Aid | Dec 21, 2016 | Substantially Equivalent |
| K160846 | AmplifEYE | Jul 14, 2016 | Substantially Equivalent |
| K152394 | Rapicide PA High-Level Disinfectant Test Strips | Mar 11, 2016 | Substantially Equivalent |
| K151522 | DEFENDO Bronchoscopy Suction Valve | Sep 17, 2015 | Substantially Equivalent |
| K133724 | MINNCARE HD | Aug 27, 2014 | Substantially Equivalent |
| K993042 | MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT | Aug 17, 2000 | Substantially Equivalent |
| K914145 | DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES | Feb 22, 1994 | Substantially Equivalent |
| K862402 | OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES | Feb 3, 1987 | Substantially Equivalent |