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FDA 510(k)

IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT

K-Number: K102572 · 2010-12-27

ApplicantSainath Intellectual Properties, LLC
Decision Date2010-12-27
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sainath Intellectual Properties, LLC. It received FDA 510(k) clearance on 2010-12-27 under 510(k) number K102572. 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 IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT?

IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT is a medical device that received FDA 510(k) clearance on 2010-12-27. The listed applicant is Sainath Intellectual Properties, LLC. The 510(k) number is K102572.

When did IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT receive FDA 510(k) clearance?

IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT received FDA 510(k) clearance on 2010-12-27, under 510(k) number K102572.

Who is the listed applicant for IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT?

The FDA 510(k) record lists Sainath Intellectual Properties, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT?

The FDA product code for IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT is KNT.

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Other records listing Sainath Intellectual Properties, 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.

K100173IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KITK092049IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT

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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