Karl Storz Suction Catheters
FDA 510(k) K951250 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK951250
Submission
- Device name
- Karl Storz Suction Catheters
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US - Received
- March 20, 1995
- Decision date
- September 7, 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 |
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More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and AccessoriesEQN · Traditional | 05/15/2026SE |
| K240506 | KARL STORZ HoldersOCV · Traditional | 10/22/2024SE |
| K223885 | HOPKINS TelescopesHIH · Traditional | 09/14/2023SE |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP)…GCJ · Traditional | 06/23/2023SE |
| K223520 | UNIDRIVE SIII SystemHIH · Traditional | 04/27/2023SE |
| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
| K222504 | H1GCJ · Traditional | 11/10/2022SE |
| K213194 | HD MediastinoscopeEWY · Traditional | 06/23/2022SE |
Questions and answers
When was Karl Storz Suction Catheters cleared by the FDA?
Karl Storz Suction Catheters (K951250) received a 510(k) decision of Substantially Equivalent on September 7, 1995, 171 days after the submission was received.
What is the product code of K951250?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.