FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-VENT REUTER BOBBIN TUBE
K Number: K870877
·
Decision Mar 26, 1987
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
114
Applicant Total
71
Review Days
23
Basic Information
- Device Name
- BIO-VENT REUTER BOBBIN TUBE
- K Number
- K870877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- RICHARDS MEDICAL CO., INC.
- Date Received
- March 3, 1987
- Decision Date
- March 26, 1987
- Product Code
- ETD
- 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 |
|---|---|---|---|
| ETD | Tube, Tympanostomy | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETD), ordered by most recent decision date.
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
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Solo+ Tympanostomy Tube Device (TTD)
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Biowy Tym Tube (TT)
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Tympanostomy Tubes
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FDA Class 2
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Hummingbird Tympanostomy Tube System
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FDA Class 2
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Hummingbird Tympanostomy Tube System
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Other Clearances by RICHARDS MEDICAL CO., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K896106 | ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS | Jun 25, 1990 | Substantially Equivalent for Some Indications |
| K900628 | MODULAR HIP SYSTEM | May 9, 1990 | Substantially Equivalent for Some Indications |
| K896580 | UNI-POLAR HEAD | Feb 15, 1990 | Substantially Equivalent |
| K895241 | INTRAMEDULLARY HIP SCREW | Jan 4, 1990 | Substantially Equivalent |
| K884824 | TRICON-M TOTAL KNEE SYSTEM | Nov 21, 1989 | Substantially Equivalent for Some Indications |
| K896204 | ZIRCONIA CERAMIC HEAD ADD'L SIZES | Nov 20, 1989 | Substantially Equivalent for Some Indications |
| K895242 | PAPPAS TRI-FLANGE VENTILATION TUBE | Nov 17, 1989 | Substantially Equivalent |
| K893377 | RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS | Nov 16, 1989 | Substantially Equivalent |
| K885069 | ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) | Sep 1, 1989 | Substantially Equivalent for Some Indications |
| K890132 | POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP. | Jul 19, 1989 | Substantially Equivalent for Some Indications |