FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAPILLOTOME
K Number: K901434
·
Decision Jun 8, 1990
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
22
Review Days
74
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Basic Information
- Device Name
- PAPILLOTOME
- K Number
- K901434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Telemed Systems, Inc.
- Date Received
- March 26, 1990
- Decision Date
- June 8, 1990
- Product Code
- KWS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWS), ordered by most recent decision date.
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AETOS Shoulder System Meta Humeral Prosthesis Size 0
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MyShoulder Planner (5.3SSWPL)
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Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
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Tornier Humeral Reconstruction System (Tornier HRS)
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Other Clearances by Telemed Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020379 | PPD BALLOON DILATATION CATHETER | May 6, 2002 | Substantially Equivalent |
| 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 |