FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
K Number: K991002
·
Decision Jun 11, 1999
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
8
Review Days
78
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Basic Information
- Device Name
- PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
- K Number
- K991002
- 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
- V. Mueller Neuro/Spine
- Date Received
- March 25, 1999
- Decision Date
- June 11, 1999
- 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 V. Mueller Neuro/Spine
| K Number | Device Name | ||
|---|---|---|---|
| K002276 | PSI SKULL CLAMP | Aug 29, 2000 | Substantially Equivalent |
| K993019 | PACIFIC SURGICAL PATTIES | Mar 30, 2000 | Substantially Equivalent |
| K991959 | PSI TITANIUM ANEURYSM CLIP | Jan 6, 2000 | Substantially Equivalent |
| K972750 | TAKA ANEURYSM CLIP | Jul 9, 1998 | Substantially Equivalent |
| K964402 | VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM | Jan 23, 1997 | Substantially Equivalent |
| K942601 | PSI FLEXIBLE ARM | Dec 27, 1994 | Substantially Equivalent |
| K943635 | ULTRA-LINE RONGEUR | Dec 7, 1994 | Substantially Equivalent |