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FDA 510(k)

STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)

K-Number: K952151 · 1996-03-04

ApplicantStorz
Decision Date1996-03-04
Product CodeHQR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) is the device name listed in this FDA 510(k) record. The listed applicant is Storz. It received FDA 510(k) clearance on 1996-03-04 under 510(k) number K952151. The device is classified under product code HQR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)?

STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) is a medical device that received FDA 510(k) clearance on 1996-03-04. The listed applicant is Storz. The 510(k) number is K952151.

When did STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) receive FDA 510(k) clearance?

STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) received FDA 510(k) clearance on 1996-03-04, under 510(k) number K952151.

Who is the listed applicant for STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)?

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

What is the FDA product code for STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)?

The FDA product code for STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) is HQR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Storz 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.

K960007STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATORK954340STORZ MICROFLOW PHACOEMULSIFICATION NEEDLEK930278STORZ COMPUSCAN ABK926512STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVEK913504STORZ MICRO CUTTER 25 GAUGE PACK

Related Devices (Code: HQR)

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.

K050308THERMAL CAUTERY PROBEStarion InstrumentsK990064DI-RHEX OPHTHALMIC DIATHERMY SYSTEMOphthalmic Technologies, Inc.K980522REFRACTEC MCS-100Refractec, Inc.K972749PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)C.M. Chance , Ltd.K955158SURGITRONEllman Intl., Inc.K952569GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATORGamp & Assoc.

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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