FDA 510(k)
FDA class 1
Substantially Equivalent
🇸🇪 Sweden
SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
K Number: K942495
·
Decision Feb 21, 1995
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
18
Applicant Total
15
Review Days
280
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Basic Information
- Device Name
- SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
- K Number
- K942495
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Atos Medical AB
- Date Received
- May 17, 1994
- Decision Date
- February 21, 1995
- Product Code
- KAM
- 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 |
|---|---|---|---|
| KAM | Cannula, Sinus | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KAM), ordered by most recent decision date.
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
FDA 510(k)
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MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RELIEVA STRATUS MICROFLOW SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SINUS SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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|---|---|---|---|
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| K141380 | PROVOX FREEHANDS FLEXIVOICE | Sep 26, 2014 | Substantially Equivalent |
| K131947 | PROVOX VEGA PUNCTURE SET | Oct 18, 2013 | Substantially Equivalent |
| K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | Oct 14, 2010 | Unknown |
| K090455 | PROVOX VEGA, MODEL 8130-8135 | Jun 5, 2009 | Substantially Equivalent |
| K072582 | PROVOX MICRON HME | May 30, 2008 | Substantially Equivalent |
| K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 | Nov 22, 2004 | Substantially Equivalent |
| K022125 | PROVOX FREEHANDS HME, MODEL 7710 | Jul 30, 2002 | Substantially Equivalent |
| K014102 | PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 | Feb 21, 2002 | Substantially Equivalent |
| K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM | Jun 6, 1997 | Substantially Equivalent |