FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPTICAL CATHETER(TM) INTRODUCER SETS
K Number: K895041
·
Decision Oct 16, 1989
Classifications
1
FEI Numbers
214
Registration Numbers
214
Same Product Code
28
Applicant Total
18
Review Days
68
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Basic Information
- Device Name
- OPTICAL CATHETER(TM) INTRODUCER SETS
- K Number
- K895041
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medical Dynamics, Inc.
- Date Received
- August 9, 1989
- Decision Date
- October 16, 1989
- Product Code
- KGZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KGZ | Accessories, Catheter | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGZ), ordered by most recent decision date.
AART SILICONE TUBING
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BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
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WOUND DRAINAGE HOLDER
FDA 510(k)
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DURALASTIC SILICONE TUBING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAVARRE PERCUTANEOUS ACCESS SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PALESTRANT IRRIGATION AND DRAINAGE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K913986 | CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM | Jan 28, 1992 | Unknown |
| 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 |