FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE
K Number: K912843
·
Decision Sep 24, 1991
Classifications
1
FEI Numbers
373
Registration Numbers
373
Same Product Code
14
Applicant Total
20
Review Days
90
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Basic Information
- Device Name
- FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE
- K Number
- K912843
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Flexmedics
- Date Received
- June 26, 1991
- Decision Date
- September 24, 1991
- Product Code
- HXB
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HXB | Probe | FDA class 1 | Orthopedic |
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Other Clearances by Flexmedics
| K Number | Device Name | ||
|---|---|---|---|
| K990765 | FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO | Mar 15, 1999 | Substantially Equivalent |
| K964955 | FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING | Feb 14, 1997 | Substantially Equivalent |
| K952430 | FINESSE GUIDEWIRE CORONARY | Aug 18, 1995 | Substantially Equivalent |
| K943390 | FLEXFINDER GUIDEWIRE | Jun 27, 1995 | Substantially Equivalent |
| K942074 | FLEXFINDER GUIDEWIRE | Jun 24, 1994 | Substantially Equivalent |
| K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE | Jan 21, 1994 | Substantially Equivalent |
| K910674 | FLEXMEDICS MALLEABLE CANNULA | Apr 12, 1991 | Substantially Equivalent |
| K895899 | FLEXMEDICS GUIDEWIRE .012 ONLY | May 23, 1990 | Substantially Equivalent |
| K893626 | FLEXMEDICS GUIDEWIRE | Sep 26, 1989 | Substantially Equivalent |
| K885086 | TIN COATED NITI ORTHODONTIC ARCH WIRES | Jan 10, 1989 | Substantially Equivalent |