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)

MILEX BARTHOLIN GLAND CATHETER

K-Number: K861385 · 1986-06-16

ApplicantMilex Products, Inc.
Decision Date1986-06-16
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MILEX BARTHOLIN GLAND CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Milex Products, Inc.. It received FDA 510(k) clearance on 1986-06-16 under 510(k) number K861385. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILEX BARTHOLIN GLAND CATHETER?

MILEX BARTHOLIN GLAND CATHETER is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is Milex Products, Inc.. The 510(k) number is K861385.

When did MILEX BARTHOLIN GLAND CATHETER receive FDA 510(k) clearance?

MILEX BARTHOLIN GLAND CATHETER received FDA 510(k) clearance on 1986-06-16, under 510(k) number K861385.

Who is the listed applicant for MILEX BARTHOLIN GLAND CATHETER?

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

What is the FDA product code for MILEX BARTHOLIN GLAND CATHETER?

The FDA product code for MILEX BARTHOLIN GLAND CATHETER is KNA.

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 Milex Products, 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.

K001545PIPET CURETK904774INGLAT-O-BALLK904026INFLAT-O-BALLK900903KOPANS HOOKWIRE LESION LOCALIZATION NEEDLEK882628ENDO C BRUSHK862410MILEX KEGEL PERINEAL EXERCISER

View all 8 devices →

Related Devices (Code: KNA)

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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLCK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/GynK060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/Gyn

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.

↑