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FDA 510(k)

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM

K-Number: K112342 · 2012-04-26

ApplicantConvatec, Inc.
Decision Date2012-04-26
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, Inc.. It received FDA 510(k) clearance on 2012-04-26 under 510(k) number K112342. 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 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM?

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-26. The listed applicant is Convatec, Inc.. The 510(k) number is K112342.

When did FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM receive FDA 510(k) clearance?

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM received FDA 510(k) clearance on 2012-04-26, under 510(k) number K112342.

Who is the listed applicant for FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM?

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

What is the FDA product code for FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM?

The FDA product code for FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM is KNT.

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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.

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