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)

LIB SYSTEM, BABY/ADULT DIAPER

K-Number: K891686 · 1989-05-31

ApplicantIntera Corp.
Decision Date1989-05-31
Product CodeEYQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LIB SYSTEM, BABY/ADULT DIAPER is the device name listed in this FDA 510(k) record. The listed applicant is Intera Corp.. It received FDA 510(k) clearance on 1989-05-31 under 510(k) number K891686. The device is classified under product code EYQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIB SYSTEM, BABY/ADULT DIAPER?

LIB SYSTEM, BABY/ADULT DIAPER is a medical device that received FDA 510(k) clearance on 1989-05-31. The listed applicant is Intera Corp.. The 510(k) number is K891686.

When did LIB SYSTEM, BABY/ADULT DIAPER receive FDA 510(k) clearance?

LIB SYSTEM, BABY/ADULT DIAPER received FDA 510(k) clearance on 1989-05-31, under 510(k) number K891686.

Who is the listed applicant for LIB SYSTEM, BABY/ADULT DIAPER?

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

What is the FDA product code for LIB SYSTEM, BABY/ADULT DIAPER?

The FDA product code for LIB SYSTEM, BABY/ADULT DIAPER is EYQ.

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 Intera Corp. 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.

K885185INTERA SHIELD AND INTERA UNDERGARMENTK883787REUSABLE ADULT INCONTINENT DIAPERK883424SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TABK863732SURGICAL DRAPE & DRAPE ACCESSORIESK862380MATTRESS COVER

Related Devices (Code: EYQ)

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.

K950784DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEMAdvanced Bioresearch Assoc.K932310KIT PAK INCONTINENT SKIN CARE KITKit Pak, Inc.K903342DEODORIZING AND SOUND MUFFLING ANAL PADBiological Resistance, Inc.K885185INTERA SHIELD AND INTERA UNDERGARMENTIntera Corp.K883895DRIPRIDE ULTRA INCONTINENT PADWeyerhaeuser Co.K883894DRIPRIDE PROVIDE SLIMWeyerhaeuser Co.

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.

↑