FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SILASTIC PERCUTANEOUS GASTROINTEST. TUBE
K Number: K760945
·
Decision Nov 23, 1976
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
31
Review Days
22
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Basic Information
- Device Name
- SILASTIC PERCUTANEOUS GASTROINTEST. TUBE
- K Number
- K760945
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Date Received
- November 1, 1976
- Decision Date
- November 23, 1976
- 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 |
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Other Clearances by Dow Corning Corp. Healthcare Industries Materials
| K Number | Device Name | ||
|---|---|---|---|
| K853186 | SILASTIC INFLATABLE BONE PLUG H.P. | Sep 24, 1985 | Substantially Equivalent |
| K844637 | WHITESIDE ACRYLIC CEMENT SPACER SLEEVE | Jun 19, 1985 | Substantially Equivalent |
| K850255 | DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET | May 1, 1985 | Substantially Equivalent |
| K843995 | TF-II HIP PROSTHESIS | Apr 23, 1985 | Substantially Equivalent |
| K842559 | WHITESIDE ORTHOLOC TOTAL HIP FEMORAL | Dec 20, 1984 | Substantially Equivalent |
| K840357 | SSA HIP PROSTHESIS | Feb 17, 1984 | Substantially Equivalent |
| K831479 | METAL-BACKED ACETABULAR CUP | Jun 15, 1983 | Substantially Equivalent |
| K812864 | SILASTIC VOICE PROSTHESIS | Nov 24, 1981 | Substantially Equivalent |
| K812053 | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | Aug 18, 1981 | Substantially Equivalent |
| K811679 | SILASTIC TENDON PASSER H.P. | Jul 10, 1981 | Substantially Equivalent |