FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE
K Number: K800623
·
Decision Apr 24, 1980
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
2
Applicant Total
39
Review Days
36
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Basic Information
- Device Name
- JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE
- K Number
- K800623
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Pilling Co.
- Date Received
- March 19, 1980
- Decision Date
- April 24, 1980
- Product Code
- KCD
- 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 |
|---|---|---|---|
| KCD | Bougie, Esophageal, Ent | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCD), ordered by most recent decision date.
VOLUMATIC
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ESOPHAGEAL BOUGIES
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Pilling Co.
| K Number | Device Name | ||
|---|---|---|---|
| K934427 | PILLING LAPAROSCOPIC INSTRUMENTATION | Jan 10, 1994 | Substantially Equivalent |
| K925370 | TRIANGULAR JAW MICROLARYNGEAL FORCEPS | Mar 18, 1993 | Substantially Equivalent |
| K925198 | KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR | Feb 12, 1993 | Substantially Equivalent |
| K922971 | NO-SCALPEL VASCETOMY INSTRUMENTS | Sep 23, 1992 | Substantially Equivalent |
| K914015 | CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP | Nov 21, 1991 | Substantially Equivalent |
| K911099 | MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE | Jun 25, 1991 | Substantially Equivalent |
| K911100 | MEHIGAN-PILLING PHLEBETOME TM | Jun 21, 1991 | Substantially Equivalent |
| K904507 | PILLING BRUSH VALVULOTOME | Mar 1, 1991 | Substantially Equivalent |
| K884946 | JEHLE CORONARY PERFUSION CATHETERS | Feb 6, 1989 | Substantially Equivalent |
| K882930 | LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX | Aug 16, 1988 | Substantially Equivalent |