Hasson Open Laparoscopy Cannula
FDA 510(k) K942447 · Linvatec Corp.
510(k) numberK942447
Submission
- Device name
- Hasson Open Laparoscopy Cannula
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- May 23, 1994
- Decision date
- December 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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Questions and answers
When was Hasson Open Laparoscopy Cannula cleared by the FDA?
Hasson Open Laparoscopy Cannula (K942447) received a 510(k) decision of Substantially Equivalent on December 15, 1994, 206 days after the submission was received.
What is the product code of K942447?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.