Angioscope W/Integrated Irrigating Channel
FDA 510(k) K881469 · Baxter Healthcare Corp
510(k) numberK881469
Submission
- Device name
- Angioscope W/Integrated Irrigating Channel
- Applicant
- Baxter Healthcare Corp
Santa Ana, CA, US - Received
- April 7, 1988
- Decision date
- September 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FER – Anoscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine and perform procedures within the anus and rectum.
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Questions and answers
When was Angioscope W/Integrated Irrigating Channel cleared by the FDA?
Angioscope W/Integrated Irrigating Channel (K881469) received a 510(k) decision of Substantially Equivalent on September 12, 1988, 158 days after the submission was received.
What is the product code of K881469?
The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.