Deroyal Industries Disposable Surgical Trocar/Cannula
FDA 510(k) K974763 · Deroyal Industries, Inc.
510(k) numberK974763
Submission
- Device name
- Deroyal Industries Disposable Surgical Trocar/Cannula
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- December 19, 1997
- Decision date
- July 10, 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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| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
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| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal…BZT · Traditional | 04/02/2020SE |
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| K173072 | Algidex Ag Silver Alginate Wound DressingFRO · Traditional | 04/04/2018SE |
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Questions and answers
When was Deroyal Industries Disposable Surgical Trocar/Cannula cleared by the FDA?
Deroyal Industries Disposable Surgical Trocar/Cannula (K974763) received a 510(k) decision of Substantially Equivalent on July 10, 1998, 203 days after the submission was received.
What is the product code of K974763?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.