Excel Pulsed Irrigation/Suction System
FDA 510(k) K873466 · Stryker Corp.
510(k) numberK873466
Submission
- Device name
- Excel Pulsed Irrigation/Suction System
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- August 28, 1987
- Decision date
- November 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FQH – Lavage, Jet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5475
- Specialty
- General Hospital
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| K213616 | BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional | Becton, Dickinson and Company | 03/23/2022SE |
| K210536 | Irrisept Antimicrobial Wound LavageFQH · Traditional | Irrimax Corporation | 05/28/2021SE |
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Questions and answers
When was Excel Pulsed Irrigation/Suction System cleared by the FDA?
Excel Pulsed Irrigation/Suction System (K873466) received a 510(k) decision of Substantially Equivalent on November 6, 1987, 70 days after the submission was received.
What is the product code of K873466?
The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.