FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STOMACH EVACULATOR - EWALD STYLE
K Number: K864963
·
Decision Oct 14, 1987
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
31
Review Days
296
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Basic Information
- Device Name
- STOMACH EVACULATOR - EWALD STYLE
- K Number
- K864963
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medovations, Inc.
- Date Received
- December 22, 1986
- Decision Date
- October 14, 1987
- Product Code
- KOA
- 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 |
|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | FDA class 1 | Gastroenterology, Urology |
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Other Clearances by Medovations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142068 | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE | Mar 10, 2015 | Substantially Equivalent |
| 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 |
| 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 |