FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISSECTING OBTURATOR
K Number: K954463
·
Decision Oct 23, 1995
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
49
Review Days
28
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Basic Information
- Device Name
- DISSECTING OBTURATOR
- K Number
- K954463
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phx Technologies Corp.
- Date Received
- September 25, 1995
- Decision Date
- October 23, 1995
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Phx Technologies Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K974327 | WINGED NEEDLE HOLDER | Jan 9, 1998 | Substantially Equivalent |
| K971123 | STONE EXTRACTOR | Jun 27, 1997 | Substantially Equivalent |
| K954508 | RETRACTOR | Nov 14, 1995 | Substantially Equivalent |
| K954509 | PROBE KNIFE | Nov 14, 1995 | Substantially Equivalent |
| K954507 | RETROGRADE KNIFE | Nov 14, 1995 | Substantially Equivalent |
| K954510 | RRIANGLE KNIFE | Nov 14, 1995 | Substantially Equivalent |
| K954459 | CONICAL OBTURATOR | Oct 23, 1995 | Substantially Equivalent |
| K954475 | BLUNT DISSECTOR, CURVED | Oct 23, 1995 | Substantially Equivalent |
| K954464 | CARPAL TUNNEL SLOTTED CANNULA | Oct 23, 1995 | Substantially Equivalent |
| K954458 | BOAT NOSE OBTURATOR | Oct 23, 1995 | Substantially Equivalent |