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FDA 510(k)

LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE

K-Number: K130305 · 2013-07-24

ApplicantLina Medical Aps
Decision Date2013-07-24
Product CodeHIN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE 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 2013-07-24 under 510(k) number K130305. The device is classified under product code HIN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE?

LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE is a medical device that received FDA 510(k) clearance on 2013-07-24. The listed applicant is Lina Medical Aps. The 510(k) number is K130305.

When did LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE receive FDA 510(k) clearance?

LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE received FDA 510(k) clearance on 2013-07-24, under 510(k) number K130305.

Who is the listed applicant for LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE?

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 BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE?

The FDA product code for LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE is HIN.

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Related Devices (Code: HIN)

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.

K122983KSEA BIPOLAR ELECTRODEKARL STORZ Endoscopy-America, Inc.K122605PKS BILLGyrus Acmi, Inc.K113080TUBALGATORMectra Labs, Inc.K111751VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSETHICON, Inc.K111059GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)Gyrus Acmi, Inc.K990147BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771Richard Wolf Medical Instruments Corp.

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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