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FDA 510(k)

ENDOSTAR(TM) STYLET

K-Number: K933598 · 1994-01-25

ApplicantFiberoptic Medical Products, Inc.
Decision Date1994-01-25
Product CodeBSR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENDOSTAR(TM) STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Fiberoptic Medical Products, Inc.. It received FDA 510(k) clearance on 1994-01-25 under 510(k) number K933598. The device is classified under product code BSR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSTAR(TM) STYLET?

ENDOSTAR(TM) STYLET is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is Fiberoptic Medical Products, Inc.. The 510(k) number is K933598.

When did ENDOSTAR(TM) STYLET receive FDA 510(k) clearance?

ENDOSTAR(TM) STYLET received FDA 510(k) clearance on 1994-01-25, under 510(k) number K933598.

Who is the listed applicant for ENDOSTAR(TM) STYLET?

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

What is the FDA product code for ENDOSTAR(TM) STYLET?

The FDA product code for ENDOSTAR(TM) STYLET is BSR.

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 Fiberoptic Medical Products, 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.

K944686FIBEROPTIC LARYNGOSCOPE HANDLEK921393IMAGICA MICRO-ENDOSCOPEK912252INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHTK883779WALLABY(TM) BLANKET

Related Devices (Code: BSR)

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.

K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft TipCook IncorporatedK962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDLaerdal Medical Corp.K954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)Laerdal Medical Corp.K943104MOLLOY INTUBATING STYLETTEMolloy Corp.K955238RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLERusch Intl.K953677LIGHTED FLEXGUIDE (MODIFICATION)Scientific Sales Intl., 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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