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FDA 510(k)

IRRIGATION KIT

K-Number: K883506 · 1988-12-13

ApplicantL H M Ent., Inc.
Decision Date1988-12-13
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IRRIGATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is L H M Ent., Inc.. It received FDA 510(k) clearance on 1988-12-13 under 510(k) number K883506. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION KIT?

IRRIGATION KIT is a medical device that received FDA 510(k) clearance on 1988-12-13. The listed applicant is L H M Ent., Inc.. The 510(k) number is K883506.

When did IRRIGATION KIT receive FDA 510(k) clearance?

IRRIGATION KIT received FDA 510(k) clearance on 1988-12-13, under 510(k) number K883506.

Who is the listed applicant for IRRIGATION KIT?

The FDA 510(k) record lists L H M Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRRIGATION KIT?

The FDA product code for IRRIGATION KIT is KYZ.

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 L H M Ent., 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.

K901078SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINEK901079SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATERK894610CUSTOM TRAYS, KITSK900439SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CCK894611CATHETER CARE KITS

Related Devices (Code: KYZ)

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.

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K982435IRRIGATION SYRINGE KITSub-Q, 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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