FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRA BAKER JEJUNOSTOMY TUBE
K Number: K841035
·
Decision Apr 13, 1984
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
32
Review Days
32
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Basic Information
- Device Name
- ULTRA BAKER JEJUNOSTOMY TUBE
- K Number
- K841035
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Inmed Corp.
- Date Received
- March 12, 1984
- Decision Date
- April 13, 1984
- Product Code
- KNT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Inmed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862672 | ESOPHAGEAL STETHOSCOPE WITH THERMISTOR | Oct 27, 1986 | Substantially Equivalent |
| K853162 | STERILE NASOPHARYNGEAL AIRWAY | Aug 6, 1985 | Substantially Equivalent |
| K850152 | PRECONNECTED URETHRAL CATHETER TRAY | Mar 12, 1985 | Substantially Equivalent |
| K850335 | URETEROSCOPY CATHETER | Mar 12, 1985 | Substantially Equivalent |
| K850248 | DISPOSABLE GUEDEL AIRWAY | Mar 12, 1985 | Substantially Equivalent |
| K844801 | ULTRA EXTERNAL CATHETER | Jan 15, 1985 | Substantially Equivalent |
| K842301 | DISPOSABLE LATEX BANDAGE | Nov 5, 1984 | Substantially Equivalent |
| K842866 | URETHRAL CATHETERIZATION TRAY | Sep 10, 1984 | Substantially Equivalent |
| K841040 | FOX POST NASAL BALLOON CATHETER | Aug 17, 1984 | Substantially Equivalent |
| K842865 | ESOPHAGEAL STETHOSCOPE | Aug 15, 1984 | Substantially Equivalent |