FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KSEA VAPORIZATION ELECTRODES
K Number: K961702
·
Decision Aug 29, 1996
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
57
Applicant Total
11
Review Days
119
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- KSEA VAPORIZATION ELECTRODES
- K Number
- K961702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karl Storz Endoskop GmbH
- Date Received
- May 2, 1996
- Decision Date
- August 29, 1996
- Product Code
- FAS
- 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 |
|---|---|---|---|
| FAS | Electrode, Electrosurgical, Active, Urological | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAS), ordered by most recent decision date.
Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Multi4 System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLASMA EDGE System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Resection Electrodes with HF cable
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Electrosurgical accessory
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Karl Storz Endoskop GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K973068 | KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING | Nov 7, 1997 | 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 |
| K943816 | TROCARS,CANNULAE, SHEATHS | Aug 24, 1994 | Substantially Equivalent |