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)

GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER

K-Number: K070657 · 2007-04-05

ApplicantGetinge Sourcing, LLC
Decision Date2007-04-05
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Getinge Sourcing, LLC. It received FDA 510(k) clearance on 2007-04-05 under 510(k) number K070657. 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 GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER?

GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER is a medical device that received FDA 510(k) clearance on 2007-04-05. The listed applicant is Getinge Sourcing, LLC. The 510(k) number is K070657.

When did GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER receive FDA 510(k) clearance?

GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER received FDA 510(k) clearance on 2007-04-05, under 510(k) number K070657.

Who is the listed applicant for GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER?

The FDA 510(k) record lists Getinge Sourcing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER?

The FDA product code for GETINGE 633HC SERIES VACUUM/GRAVITY 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 Getinge Sourcing, LLC 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.

K153713Getinge Series Warming CabinetK122625GETINGE 800HC- SERIES STEAM STERILIZERK120532GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEMK122071GETINGE 400HC-E / SERIES STEAM STERILIZERK120441GETINGE 700HC-E SERIES STEAM STERILIZERK103504GETINGE 400HC/500HC SERIES STEAM STERILIZER

View all 7 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.

↑