FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE
K Number: K905015
·
Decision Dec 28, 1990
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
86
Applicant Total
29
Review Days
51
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Basic Information
- Device Name
- SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE
- K Number
- K905015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Surgitek
- Date Received
- November 7, 1990
- Decision Date
- December 28, 1990
- Product Code
- LKY
- 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 |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Surgitek
| K Number | Device Name | ||
|---|---|---|---|
| K946296 | QUADRA-COIL URETERAL STENT | Mar 6, 1995 | Substantially Equivalent |
| K944391 | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM | Feb 7, 1995 | Substantially Equivalent |
| K943491 | RIGHT ANGLE UROLOGIC LASER FIBER | Aug 5, 1994 | Substantially Equivalent |
| K941952 | SURGITEK INFUSER | May 24, 1994 | Substantially Equivalent |
| K933261 | GRASPING FORCEPS | Jan 11, 1994 | Substantially Equivalent |
| K933260 | HELICAL STONE/FLATWIRE STONE BASKETS | Jan 11, 1994 | Substantially Equivalent |
| K930733 | URETERAL STENT | Jul 23, 1993 | Substantially Equivalent |
| K930483 | URETERAL CATHETER | Jul 16, 1993 | Unknown |
| K926344 | HYDROPHILIC COATED GUIDEWIRE | Mar 5, 1993 | Substantially Equivalent |
| K920451 | ENDOTEK ULTRA SYSTEM | Sep 17, 1992 | Substantially Equivalent |