FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PPD BALLOON DILATATION CATHETER
K Number: K020379
·
Decision May 6, 2002
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
22
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PPD BALLOON DILATATION CATHETER
- K Number
- K020379
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Telemed Systems, Inc.
- Date Received
- February 5, 2002
- Decision Date
- May 6, 2002
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNT), ordered by most recent decision date.
XNY Disposable Gastric Calibration Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Flexi-Seal AIR (with ENFit Connector)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
hygh-tec Drainage II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Entarik NI Feeding Tube System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORGRIP* SR NG/NI Tube Retention System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Telemed Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013737 | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON | Mar 1, 2002 | Substantially Equivalent |
| K010412 | FLEXIBLE ENDOSCOPIC SCISSORS | Apr 2, 2001 | Substantially Equivalent |
| K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD | Dec 22, 1999 | Substantially Equivalent |
| K992402 | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH | Dec 22, 1999 | Substantially Equivalent |
| K974312 | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR | Jan 21, 1998 | Substantially Equivalent |
| K974300 | TELEMED SYSTEMS RETRIEVAL BASKET | Dec 19, 1997 | Substantially Equivalent |
| K901435 | GASTROINTESTINAL CYTOLOGY BRUSH | Jul 16, 1990 | Substantially Equivalent |
| K901427 | BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON | Jun 22, 1990 | Substantially Equivalent |
| K901425 | PYLORIC BALLOON DILATOR | Jun 21, 1990 | Substantially Equivalent |
| K901424 | ESOPHAGEAL BALLOON DILATOR | Jun 21, 1990 | Substantially Equivalent |