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FDA 510(k)

KSEA BIPOLAR ELECTRODE

K-Number: K122983 · 2013-06-26

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2013-06-26
Product CodeHIN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KSEA BIPOLAR ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2013-06-26 under 510(k) number K122983. 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 KSEA BIPOLAR ELECTRODE?

KSEA BIPOLAR ELECTRODE is a medical device that received FDA 510(k) clearance on 2013-06-26. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K122983.

When did KSEA BIPOLAR ELECTRODE receive FDA 510(k) clearance?

KSEA BIPOLAR ELECTRODE received FDA 510(k) clearance on 2013-06-26, under 510(k) number K122983.

Who is the listed applicant for KSEA BIPOLAR ELECTRODE?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KSEA BIPOLAR ELECTRODE?

The FDA product code for KSEA BIPOLAR ELECTRODE is HIN.

Related Clinical Trials

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Other records listing KARL STORZ Endoscopy-America, 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.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

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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.

K130305LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZELina Medical ApsK122605PKS 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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