FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
NEPHROSTOMY SET
K Number: K862742
·
Decision Oct 31, 1986
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
55
Applicant Total
24
Review Days
102
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Basic Information
- Device Name
- NEPHROSTOMY SET
- K Number
- K862742
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Meadox Surgimed, Inc.
- Date Received
- July 21, 1986
- Decision Date
- October 31, 1986
- Product Code
- LJE
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LJE | Catheter, Nephrostomy | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJE), ordered by most recent decision date.
Disposable Percutaneous Nephrostomy Dilatation Kit
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Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
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In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
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Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
FDA 510(k)
FDA Unclassified
·Unknown
Lawson Retrograde Nephrostomy Wire Puncture Set
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Meadox Surgimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944143 | MS CLASSIQUE BALLOON CATHETER | Mar 13, 1995 | Substantially Equivalent |
| K945061 | NOPROFILE OLBERT CATHETER SYSTEM | Mar 9, 1995 | Substantially Equivalent |
| K942382 | MS AMPLATZ EXTRA STIFF GUIDE WIRE | Aug 22, 1994 | Substantially Equivalent |
| K930201 | ACECUT SUTOMATIC BIOPSY SYSTEM | Jun 9, 1993 | Substantially Equivalent |
| K911635 | MEADOX(R) SURGIMED(R) BIOPSY GUN II | Jun 20, 1991 | Substantially Equivalent |
| K905181 | NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY | Mar 6, 1991 | Substantially Equivalent |
| K904582 | QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE | Feb 25, 1991 | Substantially Equivalent |
| K904983 | MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY | Jan 30, 1991 | Substantially Equivalent |
| K902461 | MEADOX SURGIMED BIOPSY GUN AND NEEDLE | Jul 16, 1990 | Substantially Equivalent |
| K890926 | SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE | Jun 20, 1989 | Substantially Equivalent |