Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP

K-Number: K914358 · 1991-11-19

ApplicantHobbs Medical, Inc.
Decision Date1991-11-19
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP is the device name listed in this FDA 510(k) record. The listed applicant is Hobbs Medical, Inc.. It received FDA 510(k) clearance on 1991-11-19 under 510(k) number K914358. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP?

ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP is a medical device that received FDA 510(k) clearance on 1991-11-19. The listed applicant is Hobbs Medical, Inc.. The 510(k) number is K914358.

When did ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP receive FDA 510(k) clearance?

ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP received FDA 510(k) clearance on 1991-11-19, under 510(k) number K914358.

Who is the listed applicant for ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP?

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

What is the FDA product code for ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP?

The FDA product code for ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP is EYB.

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 Hobbs Medical, 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.

K241874Aspiration Catheter (2189)K182927Pulmonary Cytology BrushK093079TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-UK030765HOBBS MISTIFIER SPRAY CATHETERK933354HOBBS MEDICAL CLEANING BRUSHK922396FUJINON FORCEPS -- MODIFICATION

View all 21 devices →

Related Devices (Code: EYB)

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.

K192183RocaTub Ureteral CatheterPromepal SamK191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.K183323UPJ Occlusion Balloon CatheterCook IncorporatedK182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook IncorporatedK182122Ureteric CathetersColoplast Corp.K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated

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.

↑