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)

14Fr Colon Decompression Set, Macon Colon Decompression Set

K-Number: K171619 · 2017-08-01

ApplicantCook Ireland, Ltd.
Decision Date2017-08-01
Product CodeFEG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

14Fr Colon Decompression Set, Macon Colon Decompression Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K171619. The device is classified under product code FEG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 14Fr Colon Decompression Set, Macon Colon Decompression Set?

14Fr Colon Decompression Set, Macon Colon Decompression Set is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K171619.

When did 14Fr Colon Decompression Set, Macon Colon Decompression Set receive FDA 510(k) clearance?

14Fr Colon Decompression Set, Macon Colon Decompression Set received FDA 510(k) clearance on 2017-08-01, under 510(k) number K171619.

Who is the listed applicant for 14Fr Colon Decompression Set, Macon Colon Decompression Set?

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

What is the FDA product code for 14Fr Colon Decompression Set, Macon Colon Decompression Set?

The FDA product code for 14Fr Colon Decompression Set, Macon Colon Decompression Set is FEG.

Other records listing Cook Ireland, Ltd. 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.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesPMA P200023Stent, iliac veinPMA P050017STENT, ILIACPMA P100022Stent, superficial femoral artery, drug-elutingK241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)K233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)

View all 20 devices →

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.

↑