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)

SHARPE ENDOLIGATURE CARRIER

K-Number: K915749 · 1992-10-20

ApplicantPaladin Medical, Inc.
Decision Date1992-10-20
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SHARPE ENDOLIGATURE CARRIER is the device name listed in this FDA 510(k) record. The listed applicant is Paladin Medical, Inc.. It received FDA 510(k) clearance on 1992-10-20 under 510(k) number K915749. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPE ENDOLIGATURE CARRIER?

SHARPE ENDOLIGATURE CARRIER is a medical device that received FDA 510(k) clearance on 1992-10-20. The listed applicant is Paladin Medical, Inc.. The 510(k) number is K915749.

When did SHARPE ENDOLIGATURE CARRIER receive FDA 510(k) clearance?

SHARPE ENDOLIGATURE CARRIER received FDA 510(k) clearance on 1992-10-20, under 510(k) number K915749.

Who is the listed applicant for SHARPE ENDOLIGATURE CARRIER?

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

What is the FDA product code for SHARPE ENDOLIGATURE CARRIER?

The FDA product code for SHARPE ENDOLIGATURE CARRIER is HET.

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 Paladin 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.

K993306NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)K970347MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEMK971290STRATASYS FDM MEDMODELER SYSTEMK964222ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANINGK950054ENDO-BEND(TM) SHAVERK935220CORE PREVENT MATTRESS MODIFICATION

View all 14 devices →

Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , 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.

↑