Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

C-FLEX PENROSE DRAINAGE TUBE

K-Number: K833061 · 1983-11-07

ApplicantConcept, Inc.
Decision Date1983-11-07
Product CodeFFA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

C-FLEX PENROSE DRAINAGE TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1983-11-07 under 510(k) number K833061. The device is classified under product code FFA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-FLEX PENROSE DRAINAGE TUBE?

C-FLEX PENROSE DRAINAGE TUBE is a medical device that received FDA 510(k) clearance on 1983-11-07. The listed applicant is Concept, Inc.. The 510(k) number is K833061.

When did C-FLEX PENROSE DRAINAGE TUBE receive FDA 510(k) clearance?

C-FLEX PENROSE DRAINAGE TUBE received FDA 510(k) clearance on 1983-11-07, under 510(k) number K833061.

Who is the listed applicant for C-FLEX PENROSE DRAINAGE TUBE?

The FDA 510(k) record lists Concept, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-FLEX PENROSE DRAINAGE TUBE?

The FDA product code for C-FLEX PENROSE DRAINAGE TUBE is FFA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Concept, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

View all 83 devices →

Related Devices (Code: FFA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K944290CATHETERS, BILIARY CATHETERS, UROLOGICALBoston Scientific CorpK864770SUCTION TUBENew England Surgical Instrument Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑