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)

TRANSVAGINAL TRANSDUCER ASSEMBLY

K-Number: K900838 · 1990-05-23

ApplicantPie Medical Equipment B.V.
Decision Date1990-05-23
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRANSVAGINAL TRANSDUCER ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Equipment B.V.. It received FDA 510(k) clearance on 1990-05-23 under 510(k) number K900838. The device is classified under product code HGL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSVAGINAL TRANSDUCER ASSEMBLY?

TRANSVAGINAL TRANSDUCER ASSEMBLY is a medical device that received FDA 510(k) clearance on 1990-05-23. The listed applicant is Pie Medical Equipment B.V.. The 510(k) number is K900838.

When did TRANSVAGINAL TRANSDUCER ASSEMBLY receive FDA 510(k) clearance?

TRANSVAGINAL TRANSDUCER ASSEMBLY received FDA 510(k) clearance on 1990-05-23, under 510(k) number K900838.

Who is the listed applicant for TRANSVAGINAL TRANSDUCER ASSEMBLY?

The FDA 510(k) record lists Pie Medical Equipment B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSVAGINAL TRANSDUCER ASSEMBLY?

The FDA product code for TRANSVAGINAL TRANSDUCER ASSEMBLY is HGL.

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 Pie Medical Equipment B.V. 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.

K982203CAAS II LVA BIPLANE OPTIONK945540CAAS IIK915647DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250K912819SC1150 CW/PDK911584DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480K911043HEMISPHERE MULTIPLANE ENDORECTAL PROBE

View all 8 devices →

Related Devices (Code: HGL)

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.

K952031ULTRASOUND TRANSDUCER, MODEL US917Advanced Medical Systems, Inc.K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONAdvanced Medical Systems, Inc.K924516OP3/VP4Huntleigh Technology, Inc.K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMAdvanced Technology Laboratories, Inc.K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBEHitachi Medical Corp. of AmericaK901142MER MULTIPLANE VAGINAL PROBE (MVP)Medical Equipment Resources

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.

↑