FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONCEPT T-TUBE
K Number: K832361
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
83
Review Days
88
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Basic Information
- Device Name
- CONCEPT T-TUBE
- K Number
- K832361
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Concept, Inc.
- Date Received
- July 18, 1983
- Decision Date
- October 14, 1983
- 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.
Tula Tympanostomy Tube Delivery Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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))
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Solo+ Tympanostomy Tube Device (TTD)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Biowy Tym Tube (TT)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Tympanostomy Tubes
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Hummingbird Tympanostomy Tube System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Concept, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912640 | CONCEPT ENDOSTEAL FIXATION DEVICE | May 1, 1992 | Substantially Equivalent |
| K912957 | CONCEPT MICROMILL | Oct 4, 1991 | Substantially Equivalent |
| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | Jun 5, 1990 | Substantially Equivalent for Some Indications |
| K894929 | STAPLE FIXATION SYSTEM | Aug 30, 1989 | Substantially Equivalent |
| K892376 | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) | Aug 1, 1989 | Substantially Equivalent |
| K891109 | PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE | May 8, 1989 | Substantially Equivalent |
| K881954 | CONCEPT POWER SYSTEM | Nov 9, 1988 | Substantially Equivalent |
| K884255 | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM | Nov 8, 1988 | Substantially Equivalent |
| K882121 | C-FLO SUCTION TUBE | Jun 20, 1988 | Substantially Equivalent |
| K880414 | TENDON HARVESTER | Mar 25, 1988 | Substantially Equivalent |