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)

FORCEPS, SURGICAL GYNECOLOGICAL

K-Number: K944055 · 1994-09-20

ApplicantOwens Precision Systems, Inc.
Decision Date1994-09-20
Product CodeHCZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FORCEPS, SURGICAL GYNECOLOGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Owens Precision Systems, Inc.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K944055. The device is classified under product code HCZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORCEPS, SURGICAL GYNECOLOGICAL?

FORCEPS, SURGICAL GYNECOLOGICAL is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is Owens Precision Systems, Inc.. The 510(k) number is K944055.

When did FORCEPS, SURGICAL GYNECOLOGICAL receive FDA 510(k) clearance?

FORCEPS, SURGICAL GYNECOLOGICAL received FDA 510(k) clearance on 1994-09-20, under 510(k) number K944055.

Who is the listed applicant for FORCEPS, SURGICAL GYNECOLOGICAL?

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

What is the FDA product code for FORCEPS, SURGICAL GYNECOLOGICAL?

The FDA product code for FORCEPS, SURGICAL GYNECOLOGICAL is HCZ.

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 Owens Precision Systems, 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.

K924485LAPAROSCOPY SETK924224OWENS BIOPSY FORCEPS

Related Devices (Code: HCZ)

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.

K172661Fetzer Medical Gynecological ForcepsFetzer Medical GmbH & Co. KGK092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALInstrumed International, Inc.K941528PEARL PACKING FORCEPSCook Urological, Inc.K926533Z-CLAMP FORCEPSThomasville Medical Assoc.K926531HYSTERECTOMY FORCEPSThomasville Medical Assoc.K926484CORSON MYOMA GRASPING FORCEPSThomasville Medical Assoc.

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.

↑