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)

SPYSCOPE ACCESS AND DELIVERY CATHETER

K-Number: K090170 · 2009-02-04

ApplicantBoston Scientific Corp
Decision Date2009-02-04
Product CodeODF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPYSCOPE ACCESS AND DELIVERY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2009-02-04 under 510(k) number K090170. The device is classified under product code ODF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPYSCOPE ACCESS AND DELIVERY CATHETER?

SPYSCOPE ACCESS AND DELIVERY CATHETER is a medical device that received FDA 510(k) clearance on 2009-02-04. The listed applicant is Boston Scientific Corp. The 510(k) number is K090170.

When did SPYSCOPE ACCESS AND DELIVERY CATHETER receive FDA 510(k) clearance?

SPYSCOPE ACCESS AND DELIVERY CATHETER received FDA 510(k) clearance on 2009-02-04, under 510(k) number K090170.

Who is the listed applicant for SPYSCOPE ACCESS AND DELIVERY CATHETER?

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

What is the FDA product code for SPYSCOPE ACCESS AND DELIVERY CATHETER?

The FDA product code for SPYSCOPE ACCESS AND DELIVERY CATHETER is ODF.

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 Boston Scientific Corp 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.

K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)K231328LUX-Dx II (M302); LUX-Dx II+ (M312)K133566ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUSK133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMK131700SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARESK131914OFFROAD RE-ENTRY CATHETER SYSTEM

View all 414 devices →

Related Devices (Code: ODF)

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.

K092739MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILEC-Link Micro Imaging, Inc.K091962POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200Lumenis, Inc.K052194SPYGLASS DIRECT VISUALIZATION PROBE AND OCULARBoston Scientific CorpK050403SPYGLASS DIRECT VISULATION PROBEBoston Scientific CorpK9633545 STAR MEDICAL ENDOSCOPEFive Star Medical, Inc.K943593SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEMOvamed 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.

↑