FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DRILL GUIDE
K Number: K841619
·
Decision Jul 11, 1984
Classifications
1
FEI Numbers
526
Registration Numbers
526
Same Product Code
18
Applicant Total
13
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DRILL GUIDE
- K Number
- K841619
- 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
- July 11, 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.
PARALLELING GUIDES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CIVCO STEPPER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIOPSY NEEDLE GUIDE KIT, STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
A.C.L. GUIDE KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K841618 | THREADING TUBE | 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 |