FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
K Number: K880802
·
Decision May 26, 1988
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
112
Applicant Total
28
Review Days
87
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Basic Information
- Device Name
- SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
- K Number
- K880802
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Engineering Corp.
- Date Received
- February 29, 1988
- Decision Date
- May 26, 1988
- Product Code
- FGB
- 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 |
|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Medical Engineering Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K934141 | STAND ALONE CYSTOMETROGRAM | Nov 18, 1993 | Substantially Equivalent |
| K905289 | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT | Mar 13, 1991 | Substantially Equivalent |
| K903448 | SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER | Jan 14, 1991 | Substantially Equivalent |
| K902773 | SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET | Jul 16, 1990 | Substantially Equivalent |
| K884746 | SURGITEK FLAT T-SPAN | Aug 10, 1989 | Substantially Equivalent |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | Feb 8, 1989 | Substantially Equivalent |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | Aug 11, 1988 | Substantially Equivalent |
| K880801 | SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 | May 26, 1988 | Substantially Equivalent |
| K842748 | SURGITEK RECONSTRUC-NIPPLE PROSTHESIS | Sep 26, 1984 | Substantially Equivalent |
| K832043 | SURGIKEK PENILE PROSTHESIS TAIL EXTEND | Oct 20, 1983 | Substantially Equivalent |