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)

CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR

K-Number: K801610 · 1980-08-04

ApplicantEdward Weck, Inc.
Decision Date1980-08-04
Product CodeGCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K801610. The device is classified under product code GCZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR?

CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Edward Weck, Inc.. The 510(k) number is K801610.

When did CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR receive FDA 510(k) clearance?

CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801610.

Who is the listed applicant for CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR?

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

What is the FDA product code for CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR?

The FDA product code for CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR is GCZ.

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 Edward Weck, 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.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

View all 140 devices →

Related Devices (Code: GCZ)

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.

K904536JAIN GRAFT ASSISTJain Surgical Equipment, Inc.K893870ADAMS BREAST IMPLANT PROTECTORAdept-Med Intl., Inc.K870809MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206Adept-Med Intl., Inc.K802806VISECERA RETAINERAdept-Med Intl., 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.

↑