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)

W & H LISA STEAM STERILIZER

K-Number: K022816 · 2003-02-07

ApplicantA-Dec, Inc.
Decision Date2003-02-07
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

W & H LISA STEAM STERILIZER is the device name listed in this FDA 510(k) record. The listed applicant is A-Dec, Inc.. It received FDA 510(k) clearance on 2003-02-07 under 510(k) number K022816. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the W & H LISA STEAM STERILIZER?

W & H LISA STEAM STERILIZER is a medical device that received FDA 510(k) clearance on 2003-02-07. The listed applicant is A-Dec, Inc.. The 510(k) number is K022816.

When did W & H LISA STEAM STERILIZER receive FDA 510(k) clearance?

W & H LISA STEAM STERILIZER received FDA 510(k) clearance on 2003-02-07, under 510(k) number K022816.

Who is the listed applicant for W & H LISA STEAM STERILIZER?

The FDA 510(k) record lists A-Dec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for W & H LISA STEAM STERILIZER?

The FDA product code for W & H LISA STEAM STERILIZER is FLE.

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 A-Dec, 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.

K213932A-dec 300, A-dec 500K102234A-DEC 200 DENTAL SYSTEMK100647A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMK082716A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43K082827A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENTK082985A-DEC 334/335 DELIVERY SYSTEM

View all 68 devices →

Related Devices (Code: FLE)

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.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

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.

↑