FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDO BITE BLOCK
K Number: K833491
·
Decision Apr 25, 1984
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
32
Applicant Total
19
Review Days
201
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ENDO BITE BLOCK
- K Number
- K833491
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- American Endoscopy, Inc.
- Date Received
- October 7, 1983
- Decision Date
- April 25, 1984
- Product Code
- KTI
- 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 |
|---|---|---|---|
| KTI | Bronchoscope Accessory | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTI), ordered by most recent decision date.
ClearTip TBNA Type
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LungFlow Basket Catheter
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LIA-1 Catheter (542-1)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Disposable Grasping Forceps FG-52D/FG-54D
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by American Endoscopy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853274 | AMERICAN DILATATION SYSTEM | Oct 17, 1985 | Substantially Equivalent |
| K841384 | PROXIMA 1 PH MONITOR | Jul 19, 1984 | Substantially Equivalent |
| K840818 | BIOPSY FORCEPS | Apr 13, 1984 | Substantially Equivalent |
| K833859 | TAMPONADE BALLOON CUFF | Jan 3, 1984 | Substantially Equivalent |
| K833492 | PERCUTANEOUS ENDOSCOPIC GASTROSCOPY | Nov 29, 1983 | Substantially Equivalent |
| K832458 | AUTOMATIC ENDOSCOPE | Oct 20, 1983 | Substantially Equivalent |
| K821818 | RETRIEVAL BALLOONS | Sep 24, 1982 | Substantially Equivalent |
| K821819 | PIGTAIL STENTS | Aug 20, 1982 | Substantially Equivalent |
| K822062 | BALL TIP COAGULATING ELECTRODES | Aug 19, 1982 | Substantially Equivalent |
| K821817 | PIGTAIL NASAL CATHETERS | Aug 10, 1982 | Substantially Equivalent |