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FDA 510(k)

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8

K-Number: K070315 · 2007-10-30

ApplicantLina Medical Aps
Decision Date2007-10-30
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2007-10-30 under 510(k) number K070315. The device is classified under product code KNF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8?

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 is a medical device that received FDA 510(k) clearance on 2007-10-30. The listed applicant is Lina Medical Aps. The 510(k) number is K070315.

When did LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 receive FDA 510(k) clearance?

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 received FDA 510(k) clearance on 2007-10-30, under 510(k) number K070315.

Who is the listed applicant for LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8?

The FDA 510(k) record lists Lina Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8?

The FDA product code for LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 is KNF.

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Related Devices (Code: KNF)

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.

K254303KARL STORZ SUPRALOOPKarl Storz SE & CO. KGK250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.

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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