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FDA 510(k)

INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE

K-Number: K023344 · 2002-11-06

ApplicantBowel Management Systems, LLC
Decision Date2002-11-06
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Bowel Management Systems, LLC. It received FDA 510(k) clearance on 2002-11-06 under 510(k) number K023344. 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 INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE?

INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE is a medical device that received FDA 510(k) clearance on 2002-11-06. The listed applicant is Bowel Management Systems, LLC. The 510(k) number is K023344.

When did INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE receive FDA 510(k) clearance?

INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE received FDA 510(k) clearance on 2002-11-06, under 510(k) number K023344.

Who is the listed applicant for INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE?

The FDA 510(k) record lists Bowel Management Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE?

The FDA product code for INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE is KNT.

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.

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Other records listing Bowel Management Systems, LLC 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.

K012113INDWELLING FECAL MANAGEMENT SYSTEM

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

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

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