C-Flex Penrose Drainage Tube
FDA 510(k) K833061 · Concept, Inc.
510(k) numberK833061
Submission
- Device name
- C-Flex Penrose Drainage Tube
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- September 9, 1983
- Decision date
- November 7, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFA – Tube, Drainage, Suprapubic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was C-Flex Penrose Drainage Tube cleared by the FDA?
C-Flex Penrose Drainage Tube (K833061) received a 510(k) decision of Substantially Equivalent on November 7, 1983, 59 days after the submission was received.
What is the product code of K833061?
The FDA product code is FFA – Tube, Drainage, Suprapubic, a Class II (moderate risk) device regulated under 21 CFR 876.5090.