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)

INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE

K-Number: K903962 · 1991-07-29

ApplicantApk Technology
Decision Date1991-07-29
Product CodeLRP
Advisory CommitteeSU
DecisionUnknown

Device Summary

INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Apk Technology. It received FDA 510(k) clearance on 1991-07-29 under 510(k) number K903962. The device is classified under product code LRP. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE?

INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE is a medical device that received FDA 510(k) clearance on 1991-07-29. The listed applicant is Apk Technology. The 510(k) number is K903962.

When did INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE receive FDA 510(k) clearance?

INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE received FDA 510(k) clearance on 1991-07-29, under 510(k) number K903962.

Who is the listed applicant for INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE?

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

What is the FDA product code for INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE?

The FDA product code for INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE is LRP.

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 Apk Technology 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.

K903963KITS AND TRAYS FOR ONE TIME USE ONLY

Related Devices (Code: LRP)

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.

K963723LACERATION TRAYGrand Medical ProductsK951811OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACKOsteotech, Inc.K940239EYE TRAYCush Medical ProductsK935621CUSTOM ENT PACKSAssociated MedicalK940646ORTHOPEDIC TRAY PRODUCT LINECushinduK940444GENERAL SURGERY TRAYCush Medical Products

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.

↑