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)

SUTURE RACK & NEEDLE COUNTER

K-Number: K760428 · 1976-11-02

ApplicantKleen Test Products
Decision Date1976-11-02
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURE RACK & NEEDLE COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Kleen Test Products. It received FDA 510(k) clearance on 1976-11-02 under 510(k) number K760428. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURE RACK & NEEDLE COUNTER?

SUTURE RACK & NEEDLE COUNTER is a medical device that received FDA 510(k) clearance on 1976-11-02. The listed applicant is Kleen Test Products. The 510(k) number is K760428.

When did SUTURE RACK & NEEDLE COUNTER receive FDA 510(k) clearance?

SUTURE RACK & NEEDLE COUNTER received FDA 510(k) clearance on 1976-11-02, under 510(k) number K760428.

Who is the listed applicant for SUTURE RACK & NEEDLE COUNTER?

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

What is the FDA product code for SUTURE RACK & NEEDLE COUNTER?

The FDA product code for SUTURE RACK & NEEDLE COUNTER is FSM.

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 Kleen Test Products 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.

K890039KLEEN TEST BASIN SETK890539SURE COUNT LIGHT HANDLE COVERK890098KLEEN TEST O.R. KITK853622SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030K853454SURE COUNT 5 & 10 SPONGE COUNTERK853315CAUTERY TIP CLEANING PAD

View all 17 devices →

Related Devices (Code: FSM)

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.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., 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.

↑