FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WINGED NEEDLE HOLDER
K Number: K974327
·
Decision Jan 9, 1998
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
6
Applicant Total
49
Review Days
52
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Basic Information
- Device Name
- WINGED NEEDLE HOLDER
- K Number
- K974327
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phx Technologies Corp.
- Date Received
- November 18, 1997
- Decision Date
- January 9, 1998
- Product Code
- FHQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FHQ | Holder, Needle, Gastroenterologic | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FHQ), ordered by most recent decision date.
LAPAROSCOPIC NEEDLE HOLDER
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ENDOSCOPIC NEEDLEHOLDER, MODIFICATION
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MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
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25-100,25-220 VARIOUS NEEDLE HOLDERS
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25-230 TO 25-390 VARIOUS NEEDLE HOLDERS
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·Gastroenterology, Urology
NEEDLE HOLDER, MICROVASCULAR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Phx Technologies Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K954463 | DISSECTING OBTURATOR | Oct 23, 1995 | Substantially Equivalent |