FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LARYNGECTOMY TUBE
K Number: K873992
·
Decision Mar 24, 1988
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
3
Applicant Total
20
Review Days
175
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Basic Information
- Device Name
- LARYNGECTOMY TUBE
- K Number
- K873992
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Portex, Inc.
- Date Received
- October 1, 1987
- Decision Date
- March 24, 1988
- Product Code
- KAC
- 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 |
|---|---|---|---|
| KAC | Tube, Laryngectomy | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KAC), ordered by most recent decision date.
BARTON-MAYO TRACHEOSTOMA BUTTON
FDA 510(k)
FDA Class 1
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SHILEY LARYNGECTOMY TUBE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NORTHWESTERN VOICE RESTORATION KIT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Portex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033080 | PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER | Mar 10, 2004 | Substantially Equivalent |
| K031057 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT | Jul 18, 2003 | Substantially Equivalent |
| K023793 | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR | Feb 11, 2003 | Substantially Equivalent |
| K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | Feb 27, 2002 | Substantially Equivalent |
| K014073 | HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE | Feb 13, 2002 | Substantially Equivalent |
| K874597 | THERMOVENT 600, 1200, T, 02 | Jan 19, 1988 | Substantially Equivalent |
| K862167 | MINI-TRACH KIT | Aug 6, 1986 | Substantially Equivalent |
| K842456 | JET VENTILATION ADAPTOR | Jul 6, 1984 | Substantially Equivalent |
| K833908 | IRRI-CATH | Feb 4, 1984 | Substantially Equivalent |
| K840015 | SWIVEL ADAPTOR W/ALARM PORT | Jan 17, 1984 | Substantially Equivalent |