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)

MOSS(R) STEEL BREAKAWAY(R) INTRODUCER

K-Number: K945480 · 1995-08-28

ApplicantHarry A. Schlakman
Decision Date1995-08-28
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MOSS(R) STEEL BREAKAWAY(R) INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Harry A. Schlakman. It received FDA 510(k) clearance on 1995-08-28 under 510(k) number K945480. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOSS(R) STEEL BREAKAWAY(R) INTRODUCER?

MOSS(R) STEEL BREAKAWAY(R) INTRODUCER is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Harry A. Schlakman. The 510(k) number is K945480.

When did MOSS(R) STEEL BREAKAWAY(R) INTRODUCER receive FDA 510(k) clearance?

MOSS(R) STEEL BREAKAWAY(R) INTRODUCER received FDA 510(k) clearance on 1995-08-28, under 510(k) number K945480.

Who is the listed applicant for MOSS(R) STEEL BREAKAWAY(R) INTRODUCER?

The FDA 510(k) record lists Harry A. Schlakman as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOSS(R) STEEL BREAKAWAY(R) INTRODUCER?

The FDA product code for MOSS(R) STEEL BREAKAWAY(R) INTRODUCER is KOB.

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 Harry A. Schlakman 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.

K951122CAPITOL URINE DRUG SCREEN COLLECTION KIT

Related Devices (Code: KOB)

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.

K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.K181097Cook Cystostomy Catheter SetCook IncorporatedK182709One-Step Suprapubic IntroducerCook IncorporatedK182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook IncorporatedK120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, IncorporatedK014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical Instrument 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.

↑