FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATTISON ESOPHAGEAL DILATOR
K Number: K971615
·
Decision Jul 24, 1997
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
39
Applicant Total
14
Review Days
83
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Basic Information
- Device Name
- PATTISON ESOPHAGEAL DILATOR
- K Number
- K971615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tri-Med Specialties, Inc.
- Date Received
- May 2, 1997
- Decision Date
- July 24, 1997
- 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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SMART DILATOR
FDA 510(k)
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COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
FDA 510(k)
FDA Class 2
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MAXFORCE TTS SINGLE-USE BALLOON DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Tri-Med Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970890 | #ES-32 SUCTION CATHETER 32 FR. | May 23, 1997 | Substantially Equivalent |
| K970982 | T-RX RETRIEVAL FORCEPS | May 9, 1997 | Substantially Equivalent |
| K942918 | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER | Feb 28, 1995 | Substantially Equivalent |
| K950574 | NEEDLE/CANNULA | Feb 24, 1995 | Unknown |
| K934348 | TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR | Dec 23, 1994 | Substantially Equivalent |
| K945160 | PARACENTESIS NEEDLES/CANNULAS | Nov 14, 1994 | Substantially Equivalent |
| K924549 | TRI-MED QUICK-STEP(TM) RECTAL TUBE | Feb 10, 1994 | Substantially Equivalent |
| K932015 | TRI-MED INFLATABLE ESOPHAGEAL DILATOR | Feb 3, 1994 | Substantially Equivalent |
| K932652 | TRI-MED PARACENTESIS TRAY | Nov 24, 1993 | Unknown |
| K931201 | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER | Sep 28, 1993 | Substantially Equivalent |