Surgical Trocar
FDA 510(k) K911462 · Applied Medical
510(k) numberK911462
Submission
- Device name
- Surgical Trocar
- Applicant
- Applied Medical
Bolton, MA, US - Received
- April 3, 1991
- Decision date
- April 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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Questions and answers
When was Surgical Trocar cleared by the FDA?
Surgical Trocar (K911462) received a 510(k) decision of Substantially Equivalent on April 22, 1991, 19 days after the submission was received.
What is the product code of K911462?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.