Balloon controller PB-30
FDA 510(k) K153483 · Fujifilm Medical Systems U.S.A, Inc.
510(k) numberK153483
Submission
- Device name
- Balloon controller PB-30
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
Wayne, NJ, US - Received
- December 3, 2015
- Decision date
- December 15, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDF – Colonoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Balloon controller PB-30 cleared by the FDA?
Balloon controller PB-30 (K153483) received a 510(k) decision of Substantially Equivalent on December 15, 2015, 12 days after the submission was received.
What is the product code of K153483?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.