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FDA 510(k)

SURE COUNT LIGHT HANDLE COVER

K-Number: K890539 · 1989-02-27

ApplicantKleen Test Products
Decision Date1989-02-27
Product CodeFTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURE COUNT LIGHT HANDLE COVER 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 1989-02-27 under 510(k) number K890539. The device is classified under product code FTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURE COUNT LIGHT HANDLE COVER?

SURE COUNT LIGHT HANDLE COVER is a medical device that received FDA 510(k) clearance on 1989-02-27. The listed applicant is Kleen Test Products. The 510(k) number is K890539.

When did SURE COUNT LIGHT HANDLE COVER receive FDA 510(k) clearance?

SURE COUNT LIGHT HANDLE COVER received FDA 510(k) clearance on 1989-02-27, under 510(k) number K890539.

Who is the listed applicant for SURE COUNT LIGHT HANDLE COVER?

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 SURE COUNT LIGHT HANDLE COVER?

The FDA product code for SURE COUNT LIGHT HANDLE COVER is FTA.

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 SETK890098KLEEN TEST O.R. KITK853622SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030K853454SURE COUNT 5 & 10 SPONGE COUNTERK853315CAUTERY TIP CLEANING PADK852258SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER

View all 17 devices →

Related Devices (Code: FTA)

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.

K112133OASYS SURGICAL LIGHT CONTROLLEROasys HealthcareK102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)Image Stream Medical, Inc.K081698MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)Image Stream Medical, Inc.K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERXodus Medical, Inc.K051505SCB/STERIS OR-LIGHT INTERFACE BOXKARL STORZ Endoscopy-America, Inc.K023704KSEA SCB ACC CONTROLKARL STORZ Endoscopy-America, 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.

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