FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
K Number: K913986
·
Decision Jan 28, 1992
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
18
Review Days
145
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Basic Information
- Device Name
- CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
- K Number
- K913986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Medical Dynamics, Inc.
- Date Received
- September 5, 1991
- Decision Date
- January 28, 1992
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medical Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974542 | TRUE VISION, TRUE VISION II | Feb 17, 1998 | Substantially Equivalent |
| K921294 | VIDEO ENDOSCOPE-RIGID MODIFICATION | Jul 20, 1994 | Substantially Equivalent |
| K934682 | SURGICAL VIDEO CAMERA AND ACCESSORIES | Feb 15, 1994 | Substantially Equivalent |
| K930568 | ADAIR/VERESS NEEDLE INTRODUCER SET | Jul 22, 1993 | Substantially Equivalent |
| K915538 | OVER THE WIRE STONE BASKET | Mar 20, 1992 | Substantially Equivalent |
| K914315 | OPTICAL CATHETER INTRODUCER SETS, MODIFICATION | Mar 4, 1992 | Substantially Equivalent |
| K911296 | OPTICAL CATHETER ARTHROSCOPE | Sep 24, 1991 | Substantially Equivalent |
| K903339 | VIDEO ENDOSCOPE, RIGID | Mar 6, 1991 | Substantially Equivalent |
| K904609 | XENON LIGHT SOURCE | Dec 18, 1990 | Substantially Equivalent |
| K904113 | OPERATIVE RECORDING CAMERA | Oct 30, 1990 | Substantially Equivalent |