FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES
K Number: K953368
·
Decision Sep 18, 1995
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
11
Review Days
62
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Basic Information
- Device Name
- LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES
- K Number
- K953368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karl Storz Endoskop GmbH
- Date Received
- July 18, 1995
- Decision Date
- September 18, 1995
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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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 |
| 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 |
| K943816 | TROCARS,CANNULAE, SHEATHS | Aug 24, 1994 | Substantially Equivalent |