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)

LEEP SYSTEM 1000

K-Number: K952483 · 1995-10-06

ApplicantCooperSurgical, Inc.
Decision Date1995-10-06
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LEEP SYSTEM 1000 is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 1995-10-06 under 510(k) number K952483. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEEP SYSTEM 1000?

LEEP SYSTEM 1000 is a medical device that received FDA 510(k) clearance on 1995-10-06. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K952483.

When did LEEP SYSTEM 1000 receive FDA 510(k) clearance?

LEEP SYSTEM 1000 received FDA 510(k) clearance on 1995-10-06, under 510(k) number K952483.

Who is the listed applicant for LEEP SYSTEM 1000?

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

What is the FDA product code for LEEP SYSTEM 1000?

The FDA product code for LEEP SYSTEM 1000 is HGI.

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 CooperSurgical, 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.

K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)K243799Fetal PillowK250438CooperSurgical Milex® PessariesK223064ALLY II Uterine Positioning System™ (UPS)K201086Advincula Delineator Uterine ManipulatorK200038Endosee System

View all 37 devices →

Related Devices (Code: HGI)

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.

K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLCK152843Liger Medical HTU-110Liger Medical, LLCK121881DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.K070877ENDOCERVICAL ELECTRODE # 2Modern Medical Equipment Mfg., Ltd.K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158Apple Medical Corp.K022593THOMAS MEDICAL ELECTRODESThomas Medical, 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.

↑