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FDA 510(k)

GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS

K-Number: K935198 · 1994-09-28

ApplicantLake Region Mfg., Inc.
Decision Date1994-09-28
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Mfg., Inc.. It received FDA 510(k) clearance on 1994-09-28 under 510(k) number K935198. 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 GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS?

GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS is a medical device that received FDA 510(k) clearance on 1994-09-28. The listed applicant is Lake Region Mfg., Inc.. The 510(k) number is K935198.

When did GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS receive FDA 510(k) clearance?

GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS received FDA 510(k) clearance on 1994-09-28, under 510(k) number K935198.

Who is the listed applicant for GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS?

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

What is the FDA product code for GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS?

The FDA product code for GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS is KNT.

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Other records listing Lake Region Mfg., Inc. 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.

K092965TRAILRUNNER GUIDEWIRESK082922FREEWAY AND RAILRUNNER GUIDEWIRESK081708TAXI ENDOSCOPIC GUIDEWIREK080144MANDREL GUIDEWIRES OR M-WIRESK073655PEGASUS STEERABLE (PTCA) GUIDEWIREK060454TITAN GUIDEWIRE

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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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