Ksea Hydromat 263110-20 Pressure Chambers and Accessories
FDA 510(k) K972488 · Karl Storz Endoscopy
510(k) numberK972488
Submission
- Device name
- Ksea Hydromat 263110-20 Pressure Chambers and Accessories
- Applicant
- Karl Storz Endoscopy
Culver City, CA, US - Received
- July 2, 1997
- Decision date
- January 22, 1998
- 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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| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
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Questions and answers
When was Ksea Hydromat 263110-20 Pressure Chambers and Accessories cleared by the FDA?
Ksea Hydromat 263110-20 Pressure Chambers and Accessories (K972488) received a 510(k) decision of Substantially Equivalent on January 22, 1998, 204 days after the submission was received.
What is the product code of K972488?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.