FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
K Number: K010068
·
Decision Feb 8, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
43
Review Days
31
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Basic Information
- Device Name
- RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
- K Number
- K010068
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rusch Intl.
- Date Received
- January 8, 2001
- Decision Date
- February 8, 2001
- Product Code
- ESW
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| ESW | Prosthesis, Esophageal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Rusch Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K033023 | INTERMITTENT URETHRAL CATHETERS | Dec 23, 2003 | Substantially Equivalent |
| K030559 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM | Jun 30, 2003 | Substantially Equivalent |
| K023666 | RUSCH GUIDED CHOLANGIOGRAPHY CATHETER | Jun 17, 2003 | Substantially Equivalent |
| K023918 | RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS | Mar 28, 2003 | Substantially Equivalent |
| K023964 | RUSCH MICROLARYNGEAL TUBE | Dec 23, 2002 | Substantially Equivalent |
| K021540 | RUSCH EDGAR TUBE | Aug 1, 2002 | Substantially Equivalent |
| K021764 | RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED | Jul 23, 2002 | Substantially Equivalent |
| K020714 | RUSCH FLONEIL; FLOCATH INTROGEL | Jul 1, 2002 | Substantially Equivalent |
| K010798 | RUSCH CANTOR TUBE | Feb 26, 2002 | Substantially Equivalent |
| K010797 | RUSCH MILLER-ABBOTT TUBE | Feb 26, 2002 | Substantially Equivalent |