FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LORENZ STENT
K Number: K896667
·
Decision Feb 22, 1990
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
9
Applicant Total
56
Review Days
87
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Basic Information
- Device Name
- LORENZ STENT
- K Number
- K896667
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Walter Lorenz Surgical, Inc.
- Date Received
- November 27, 1989
- Decision Date
- February 22, 1990
- Product Code
- FWN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| FWN | Prosthesis, Larynx (Stents And Keels) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FWN), ordered by most recent decision date.
RUTTER SUPRA STOMAL STENTS
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ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
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FDA Class 2
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MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
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FDA Class 2
·Ear, Nose, Throat
SILICONE LARYNGEAL STENT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
'EXMOOR' DAS GUPTA LARYNGEAL KEEL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LARYNGEAL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Walter Lorenz Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | Feb 9, 2007 | Substantially Equivalent |
| K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | Jan 12, 2007 | Substantially Equivalent |
| K063506 | LORENZ STERNAL CLOSURE SYSTEM | Dec 18, 2006 | Substantially Equivalent |
| K062842 | TWIST DRILL | Dec 4, 2006 | Substantially Equivalent |
| K061384 | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM | Jun 6, 2006 | Substantially Equivalent |
| K042516 | OTOMIMIX | Nov 8, 2004 | Substantially Equivalent |
| K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | May 14, 2004 | Substantially Equivalent |
| K040990 | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS | May 13, 2004 | Substantially Equivalent |
| K040983 | LORENZ SELF-DRILLING IMF SCREW | May 5, 2004 | Substantially Equivalent |
| K033740 | LORENZ STERNAL CLOSURE SYSTEM | Dec 15, 2003 | Substantially Equivalent |