FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KARL STORZ DIRECT COUPLED CAMERA HEAD
K Number: K973252
·
Decision Nov 24, 1997
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
95
Applicant Total
10
Review Days
87
Basic Information
- Device Name
- KARL STORZ DIRECT COUPLED CAMERA HEAD
- K Number
- K973252
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KARL STORZ IMAGING, INC.
- Date Received
- August 29, 1997
- Decision Date
- November 24, 1997
- Product Code
- FET
- 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 |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by KARL STORZ IMAGING, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K003325 | KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM | Apr 27, 2001 | Substantially Equivalent |
| K001362 | KARL STORZ 3D VIDEO SYSTEM | Jul 17, 2000 | Substantially Equivalent |
| K994090 | KARL STORZ AUTOCLAVABLE CAMERA HEAD | Feb 4, 2000 | Substantially Equivalent |
| K990154 | KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM | Jun 1, 1999 | Substantially Equivalent |
| K974391 | KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM | Jan 30, 1998 | Substantially Equivalent |
| K963333 | OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) | Oct 22, 1996 | Substantially Equivalent |
| K950862 | KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES | May 24, 1995 | Substantially Equivalent |
| K950974 | KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS | May 11, 1995 | Substantially Equivalent |
| K950975 | KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS | May 11, 1995 | Substantially Equivalent |