FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMERICAN DILATATION SYSTEM
K Number: K853274
·
Decision Oct 17, 1985
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
39
Applicant Total
19
Review Days
73
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Basic Information
- Device Name
- AMERICAN DILATATION SYSTEM
- K Number
- K853274
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Endoscopy, Inc.
- Date Received
- August 5, 1985
- Decision Date
- October 17, 1985
- 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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HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
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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 American Endoscopy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841384 | PROXIMA 1 PH MONITOR | Jul 19, 1984 | Substantially Equivalent |
| K833491 | ENDO BITE BLOCK | Apr 25, 1984 | Substantially Equivalent |
| K840818 | BIOPSY FORCEPS | Apr 13, 1984 | Substantially Equivalent |
| K833859 | TAMPONADE BALLOON CUFF | Jan 3, 1984 | Substantially Equivalent |
| K833492 | PERCUTANEOUS ENDOSCOPIC GASTROSCOPY | Nov 29, 1983 | Substantially Equivalent |
| K832458 | AUTOMATIC ENDOSCOPE | Oct 20, 1983 | Substantially Equivalent |
| K821818 | RETRIEVAL BALLOONS | Sep 24, 1982 | Substantially Equivalent |
| K821819 | PIGTAIL STENTS | Aug 20, 1982 | Substantially Equivalent |
| K822062 | BALL TIP COAGULATING ELECTRODES | Aug 19, 1982 | Substantially Equivalent |
| K821817 | PIGTAIL NASAL CATHETERS | Aug 10, 1982 | Substantially Equivalent |