Torcars,Cannulae,Sheaths,Obturators
FDA 510(k) K943713 · Karl Storz Endoskop GmbH
510(k) numberK943713
Submission
- Device name
- Torcars,Cannulae,Sheaths,Obturators
- Applicant
- Karl Storz Endoskop GmbH
Culver City, CA, US - Received
- August 1, 1994
- Decision date
- June 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K973068 | Ksea Instrument Set for Saphenous Vein HarvestingGCJ · Traditional | 11/07/1997SE |
| K961702 | Ksea Vaporization ElectrodesFAS · Traditional | 08/29/1996SE |
| K953368 | Luer, Jackson Trachea Tubes, Luer Speaking Trachea TubesBTR · Traditional | 09/18/1995SE |
| K951995 | Karl Storz Catheters, Mandrin, Plugs, ConnectorKNY · Traditional | 05/24/1995SE |
| K943053 | Ksea Semm Tissur PunchHET · Traditional | 03/21/1995SE |
| K943435 | Cholangiography SetGCJ · Traditional | 11/07/1994SE |
| K944823 | Karl Storz Insulated Dissecting Cannulae, Cannulae, Suction Tubes, Insert TubesGEI · Traditional | 11/02/1994SE |
| K943904 | Rigid TelescopesENZ · Traditional | 10/14/1994SE |
| K943697 | Trocars,Cannulae,Sheaths,ObturatorsODB · Traditional | 09/14/1994SE |
| K943816 | Trocars,Cannulae, SheathsEOB · Traditional | 08/24/1994SE |
Questions and answers
When was Torcars,Cannulae,Sheaths,Obturators cleared by the FDA?
Torcars,Cannulae,Sheaths,Obturators (K943713) received a 510(k) decision of Substantially Equivalent on June 30, 1995, 333 days after the submission was received.
What is the product code of K943713?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.