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)

MEDWORKS INSEMINATION CATHETER

K-Number: K982628 · 1998-08-21

ApplicantMedworks Corp.
Decision Date1998-08-21
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDWORKS INSEMINATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medworks Corp.. It received FDA 510(k) clearance on 1998-08-21 under 510(k) number K982628. The device is classified under product code MFD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDWORKS INSEMINATION CATHETER?

MEDWORKS INSEMINATION CATHETER is a medical device that received FDA 510(k) clearance on 1998-08-21. The listed applicant is Medworks Corp.. The 510(k) number is K982628.

When did MEDWORKS INSEMINATION CATHETER receive FDA 510(k) clearance?

MEDWORKS INSEMINATION CATHETER received FDA 510(k) clearance on 1998-08-21, under 510(k) number K982628.

Who is the listed applicant for MEDWORKS INSEMINATION CATHETER?

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

What is the FDA product code for MEDWORKS INSEMINATION CATHETER?

The FDA product code for MEDWORKS INSEMINATION CATHETER is MFD.

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 Medworks Corp. 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.

K982630MEDWORKS VISUALIZATION INSEMINATION CATHETERK982626URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0

Related Devices (Code: MFD)

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.

K021438INSEMINATION CATHETER, MODEL 320301Labotect Labor-Technik GottingenK012935THECURVE, ITEM 507Select Medical Systems, Inc.K984306`THE INSEMINATOR' (PROPOSED)Wallach Surgical Devices, Inc.K982630MEDWORKS VISUALIZATION INSEMINATION CATHETERMedworks Corp.K980061EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTERRocket Medical PlcK972823MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETERA & A 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.

↑