FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE
K Number: K934280
·
Decision Jan 13, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
49
Review Days
135
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Basic Information
- Device Name
- PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE
- K Number
- K934280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Phx Technologies Corp.
- Date Received
- August 31, 1993
- Decision Date
- January 13, 1994
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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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 |