FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRISTOL BALLON INTRODUCER, MANDRIL SET
K Number: K813332
·
Decision Dec 14, 1981
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
2
Applicant Total
32
Review Days
20
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Basic Information
- Device Name
- BRISTOL BALLON INTRODUCER, MANDRIL SET
- K Number
- K813332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Inmed Corp.
- Date Received
- November 24, 1981
- Decision Date
- December 14, 1981
- Product Code
- NWU
- 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 |
|---|---|---|---|
| NWU | Endoscope Introducer Kit | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NWU), ordered by most recent decision date.
CANDELA GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |