FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THREADING TUBE
K Number: K841618
·
Decision Aug 27, 1984
Classifications
1
FEI Numbers
526
Registration Numbers
526
Same Product Code
18
Applicant Total
13
Review Days
130
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Basic Information
- Device Name
- THREADING TUBE
- K Number
- K841618
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Plastafil, Inc.
- Date Received
- April 19, 1984
- Decision Date
- August 27, 1984
- Product Code
- FZX
- 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 |
|---|---|---|---|
| FZX | Guide, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZX), ordered by most recent decision date.
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NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
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Other Clearances by Plastafil, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841621 | BACK RADIUS CUTTER | Sep 20, 1984 | Substantially Equivalent |
| K841620 | FRONT RADIUS CUTTER | Sep 20, 1984 | Substantially Equivalent |
| K841617 | STROVER HOOK | Aug 27, 1984 | Substantially Equivalent |
| K841629 | DRILL BIT | Aug 27, 1984 | Substantially Equivalent |
| K841625 | HOOK | Aug 27, 1984 | Substantially Equivalent |
| K841624 | PROBE | Aug 27, 1984 | Substantially Equivalent |
| K841626 | PUNCH | Aug 27, 1984 | Substantially Equivalent |
| K841627 | MALLET | Aug 27, 1984 | Substantially Equivalent |
| K841628 | WIRE | Jul 23, 1984 | Substantially Equivalent |
| K841622 | SOFT-TISSUE INSTRUMENT | Jul 11, 1984 | Substantially Equivalent |