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)

DELIVERY SHEATH

K-Number: K983415 · 1998-12-01

ApplicantConway Stuart Medical, Inc.
Decision Date1998-12-01
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DELIVERY SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Conway Stuart Medical, Inc.. It received FDA 510(k) clearance on 1998-12-01 under 510(k) number K983415. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELIVERY SHEATH?

DELIVERY SHEATH is a medical device that received FDA 510(k) clearance on 1998-12-01. The listed applicant is Conway Stuart Medical, Inc.. The 510(k) number is K983415.

When did DELIVERY SHEATH receive FDA 510(k) clearance?

DELIVERY SHEATH received FDA 510(k) clearance on 1998-12-01, under 510(k) number K983415.

Who is the listed applicant for DELIVERY SHEATH?

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

What is the FDA product code for DELIVERY SHEATH?

The FDA product code for DELIVERY SHEATH is FED.

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 Conway Stuart 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.

K000245CSM STRETTA SYSTEMK000170SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000K992542TUBULAR ELECTRODE DEVICEK991529CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400K990724CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIESK991291STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION

View all 10 devices →

Related Devices (Code: FED)

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.

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific CorporationK260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

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.

↑