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FDA 510(k)

SURGIFLATOR 20

K-Number: K950035 · 1996-02-12

ApplicantW.O.M. GmbH
Decision Date1996-02-12
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURGIFLATOR 20 is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. GmbH. It received FDA 510(k) clearance on 1996-02-12 under 510(k) number K950035. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIFLATOR 20?

SURGIFLATOR 20 is a medical device that received FDA 510(k) clearance on 1996-02-12. The listed applicant is W.O.M. GmbH. The 510(k) number is K950035.

When did SURGIFLATOR 20 receive FDA 510(k) clearance?

SURGIFLATOR 20 received FDA 510(k) clearance on 1996-02-12, under 510(k) number K950035.

Who is the listed applicant for SURGIFLATOR 20?

The FDA 510(k) record lists W.O.M. GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIFLATOR 20?

The FDA product code for SURGIFLATOR 20 is HIF.

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 W.O.M. GmbH 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.

K922632WOM HYSTEROFLATOR OPK921086WOM LAPAROFLATOR ELECTRONIC

Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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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