FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SURGITEK(R) EXTERNAL FILL PORT
K Number: K894495
·
Decision Jan 17, 1990
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
29
Review Days
182
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Basic Information
- Device Name
- SURGITEK(R) EXTERNAL FILL PORT
- K Number
- K894495
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Surgitek
- Date Received
- July 19, 1989
- Decision Date
- January 17, 1990
- Product Code
- LCJ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCJ), ordered by most recent decision date.
Natrelle 133S Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs
FDA 510(k)
FDA Unclassified
·Unknown
Mentor CPX 4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
MENTOR CPX4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
Motiva Flora SmoothSilk Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
AlloX2 Pro Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
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 |