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)

COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH

K-Number: K072521 · 2007-11-20

ApplicantCook Urological, Inc.
Decision Date2007-11-20
Product CodeFFS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2007-11-20 under 510(k) number K072521. The device is classified under product code FFS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH?

COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH is a medical device that received FDA 510(k) clearance on 2007-11-20. The listed applicant is Cook Urological, Inc.. The 510(k) number is K072521.

When did COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH receive FDA 510(k) clearance?

COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH received FDA 510(k) clearance on 2007-11-20, under 510(k) number K072521.

Who is the listed applicant for COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH?

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

What is the FDA product code for COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH?

The FDA product code for COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH is FFS.

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 Cook Urological, 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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

View all 104 devices →

Related Devices (Code: FFS)

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.

K061622PS SERIESPhotonic Optische Gerate Gesmbh & CokgK063309TRU-CABLETruphatek International, Ltd.K061025ACCUTECH ENDOLITE PROBEAccutech Medical Technologies, Inc.K023633SOVIS OPTIQUE'S ENDOSCOPIC CABLESovis OptiqueK001698MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159Cogent Light Technologies, Inc.K994084SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIESSmith & Nephew, 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.

↑