FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHX TECHNOLOGIES CORP., MONOPOLAR ELECTROCAUTERY PROBE TIP CLEANER
K Number: K933896
·
Decision Dec 9, 1993
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
49
Review Days
121
Basic Information
- Device Name
- PHX TECHNOLOGIES CORP., MONOPOLAR ELECTROCAUTERY PROBE TIP CLEANER
- K Number
- K933896
- 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 10, 1993
- Decision Date
- December 9, 1993
- 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 |
| K954507 | RETROGRADE KNIFE | Nov 14, 1995 | Substantially Equivalent |
| K954509 | PROBE KNIFE | Nov 14, 1995 | Substantially Equivalent |
| K954510 | RRIANGLE KNIFE | Nov 14, 1995 | Substantially Equivalent |
| K954508 | RETRACTOR | Nov 14, 1995 | Substantially Equivalent |
| K954458 | BOAT NOSE OBTURATOR | Oct 23, 1995 | Substantially Equivalent |
| K954475 | BLUNT DISSECTOR, CURVED | Oct 23, 1995 | Substantially Equivalent |
| K954463 | DISSECTING OBTURATOR | Oct 23, 1995 | Substantially Equivalent |
| K954464 | CARPAL TUNNEL SLOTTED CANNULA | Oct 23, 1995 | Substantially Equivalent |