FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TITANIUM HEMOSTATIC CLIP
K Number: K953258
·
Decision Jan 5, 1996
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
14
Review Days
177
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Basic Information
- Device Name
- TITANIUM HEMOSTATIC CLIP
- K Number
- K953258
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intramed Laboratories, Inc.
- Date Received
- July 12, 1995
- Decision Date
- January 5, 1996
- Product Code
- FZP
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Intramed Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942457 | GRAFT THROMBECTOMY INSTRUMENTS | Feb 7, 1995 | Substantially Equivalent |
| K931792 | ARTHROSCOPE | Jun 13, 1994 | Substantially Equivalent |
| K925283 | VALVULOTOME | Feb 10, 1994 | Substantially Equivalent |
| K934696 | ANGIOSCOPE | Jan 18, 1994 | Substantially Equivalent |
| K922114 | ENDOSCOPIC RETRIEVAL BASKET | Aug 3, 1992 | Substantially Equivalent |
| K914385 | OPTICAL VALVULOTOME | Mar 2, 1992 | Substantially Equivalent |
| K904465 | FLEXIBLE ARTHROSCOPE | Dec 20, 1990 | Substantially Equivalent |
| K903528 | LAPAROSCOPE | Sep 4, 1990 | Substantially Equivalent |
| K902444 | CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP | Aug 30, 1990 | Substantially Equivalent |
| K901010 | FLEXIBLE CHOLEDOCHOSCOPE | May 22, 1990 | Substantially Equivalent |