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)

DoubleChek DC-1001

K-Number: K212316 · 2022-09-30

ApplicantNasogastric Feeding Solutions, Ltd.
Decision Date2022-09-30
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DoubleChek DC-1001 is the device name listed in this FDA 510(k) record. The listed applicant is Nasogastric Feeding Solutions, Ltd.. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K212316. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DoubleChek DC-1001?

DoubleChek DC-1001 is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Nasogastric Feeding Solutions, Ltd.. The 510(k) number is K212316.

When did DoubleChek DC-1001 receive FDA 510(k) clearance?

DoubleChek DC-1001 received FDA 510(k) clearance on 2022-09-30, under 510(k) number K212316.

Who is the listed applicant for DoubleChek DC-1001?

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

What is the FDA product code for DoubleChek DC-1001?

The FDA product code for DoubleChek DC-1001 is KNT.

Related Devices (Code: KNT)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

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.

↑