FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
K Number: K944522
·
Decision Feb 24, 1995
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
35
Applicant Total
46
Review Days
161
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Basic Information
- Device Name
- MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
- K Number
- K944522
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.5650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Device Technologies, Inc.
- Date Received
- September 16, 1994
- Decision Date
- February 24, 1995
- Product Code
- IWJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IWJ | System, Applicator, Radionuclide, Manual | FDA class 1 | Radiology |
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|---|---|---|---|
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| K051421 | INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | Aug 30, 2005 | Substantially Equivalent |
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| K043523 | INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE | Feb 11, 2005 | Substantially Equivalent |
| K042464 | V-CORE FULL CORE BREAST BIOPSY INSTRUMENT | Sep 30, 2004 | Substantially Equivalent |
| K040427 | FIBREX CATHETER PATENCY DEVICE | May 3, 2004 | Substantially Equivalent |
| K031442 | PBN GUIDEWIRES | Aug 13, 2003 | Substantially Equivalent |
| K021606 | EN-SNARE ENDOVASCULAR SNARE AND CATHETER | May 31, 2002 | Substantially Equivalent |
| K011790 | MICROCRUISER PLUS INTRODUCER SET | Sep 5, 2001 | Substantially Equivalent |