FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TROCARS,CANNULAE, SHEATHS
K Number: K943816
·
Decision Aug 24, 1994
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
11
Review Days
19
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Basic Information
- Device Name
- TROCARS,CANNULAE, SHEATHS
- K Number
- K943816
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karl Storz Endoskop GmbH
- Date Received
- August 5, 1994
- Decision Date
- August 24, 1994
- Product Code
- EOB
- 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Karl Storz Endoskop GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K973068 | KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING | Nov 7, 1997 | Substantially Equivalent |
| K961702 | KSEA VAPORIZATION ELECTRODES | Aug 29, 1996 | Substantially Equivalent |
| K953368 | LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES | Sep 18, 1995 | Substantially Equivalent |
| K943713 | TORCARS,CANNULAE,SHEATHS,OBTURATORS | Jun 30, 1995 | Substantially Equivalent |
| K951995 | KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR | May 24, 1995 | Substantially Equivalent |
| K943053 | KSEA SEMM TISSUR PUNCH | Mar 21, 1995 | Substantially Equivalent |
| K943435 | CHOLANGIOGRAPHY SET | Nov 7, 1994 | Substantially Equivalent |
| K944823 | KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES | Nov 2, 1994 | Substantially Equivalent |
| K943904 | RIGID TELESCOPES | Oct 14, 1994 | Substantially Equivalent |
| K943697 | TROCARS,CANNULAE,SHEATHS,OBTURATORS | Sep 14, 1994 | Substantially Equivalent |