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FDA 510(k)

INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR

K-Number: K972506 · 1997-10-01

ApplicantInfinitech, Inc.
Decision Date1997-10-01
Product CodeHJM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Infinitech, Inc.. It received FDA 510(k) clearance on 1997-10-01 under 510(k) number K972506. The device is classified under product code HJM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR?

INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is Infinitech, Inc.. The 510(k) number is K972506.

When did INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR receive FDA 510(k) clearance?

INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR received FDA 510(k) clearance on 1997-10-01, under 510(k) number K972506.

Who is the listed applicant for INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR?

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

What is the FDA product code for INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR?

The FDA product code for INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR is HJM.

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 Infinitech, 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.

K971950INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTERK951627INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEMK931264INFINITECH OTOPROBEK931546END-IRRIGATING ENDOILLUMINATORK935441INFINITECH BREATH EZ

Related Devices (Code: HJM)

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.

K950529PEREGRINE DIFFUSION LIGHT PIPEPeregrine Surgical , Ltd.K945877WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHTWells Johnson Co.K931072HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBEHgm, Inc.K933445DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)Storz Instrument Co.K940393PEREGRINE WIDE ANGLE LIGHT PIPEPeregrine Surgical , Ltd.K934269FIBEROPTIC ILLUMINATED INSTRUMENTSVisitec Co.

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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