FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OVER THE GUIDEWIRE DILATATION SYSTEM
K Number: K924646
·
Decision Dec 5, 1994
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
39
Applicant Total
31
Review Days
812
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Basic Information
- Device Name
- OVER THE GUIDEWIRE DILATATION SYSTEM
- K Number
- K924646
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medovations, Inc.
- Date Received
- September 14, 1992
- Decision Date
- December 5, 1994
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNQ), ordered by most recent decision date.
CRE FIXED WIRE BALLON DILATION CATHETER
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COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
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MAXFORCE TTS SINGLE-USE BALLOON DILATOR
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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 |
| 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 |