FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE
K Number: K142068
·
Decision Mar 10, 2015
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
31
Review Days
223
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Basic Information
- Device Name
- BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE
- K Number
- K142068
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medovations, Inc.
- Date Received
- July 30, 2014
- Decision Date
- March 10, 2015
- Product Code
- OCX
- 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medovations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002363 | MEDOVATIONS ESOPHAGEAL DILATOR | Nov 1, 2000 | Substantially Equivalent |
| K972119 | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | Feb 2, 1998 | Substantially Equivalent |
| K924646 | OVER THE GUIDEWIRE DILATATION SYSTEM | Dec 5, 1994 | Substantially Equivalent |
| K913678 | TROCAR CATHETER | Dec 16, 1991 | Substantially Equivalent |
| K905478 | YANKAUER SUCTION DEVICE | Dec 19, 1990 | Substantially Equivalent |
| K874309 | URETHAL CATHETER | Dec 7, 1987 | Substantially Equivalent |
| K864963 | STOMACH EVACULATOR - EWALD STYLE | Oct 14, 1987 | Substantially Equivalent |
| K864962 | OBERTO MOUTH PROP | Feb 19, 1987 | Substantially Equivalent |
| K864964 | 5 - IN - 1 CONNECTOR | Jan 20, 1987 | Substantially Equivalent |
| K854616 | ENTERAL FEEDING BAG | Jan 23, 1986 | Substantially Equivalent |