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)

ENDOMETRIAL PIPELLE

K-Number: K854415 · 1986-03-13

ApplicantUnimar, Inc.
Decision Date1986-03-13
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOMETRIAL PIPELLE is the device name listed in this FDA 510(k) record. The listed applicant is Unimar, Inc.. It received FDA 510(k) clearance on 1986-03-13 under 510(k) number K854415. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOMETRIAL PIPELLE?

ENDOMETRIAL PIPELLE is a medical device that received FDA 510(k) clearance on 1986-03-13. The listed applicant is Unimar, Inc.. The 510(k) number is K854415.

When did ENDOMETRIAL PIPELLE receive FDA 510(k) clearance?

ENDOMETRIAL PIPELLE received FDA 510(k) clearance on 1986-03-13, under 510(k) number K854415.

Who is the listed applicant for ENDOMETRIAL PIPELLE?

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

What is the FDA product code for ENDOMETRIAL PIPELLE?

The FDA product code for ENDOMETRIAL PIPELLE is HHK.

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 Unimar, 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.

K932432KRONNER REINFORCING STYLETTEK920803HSG TRAYK910317UNI-SEM(TM)K904473KRONNER MANIPUJECTORK895659HUI MINI-FLEXK895403ASPIRETTE ENDOCERVICAL ASPIRATOR

View all 10 devices →

Related Devices (Code: HHK)

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.

K251882Uterine Aspiration SetGcmedica Enterprise Ltd.(Wuxi)K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)Li Medical Corporation , Ltd.K201952CrossGlide ETS PlusCrossbay MedicalK192534CrossBay Endometrial Tissue Sampler (ETS)Crossbay MedicalK102847DISPOSABLE ENDOMETRIAL SUCTION CURETTEJiangsu Suyun Medical Materials Co., Ltd.K092982THE PANPAC SUCTION CURETTEPanpac Medical Corporation

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.

↑