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FDA 510(k)

INSUFFLATION NEEDLE- 120MM, MODEL 900-200

K-Number: K993625 · 2000-06-20

ApplicantGenicon, LC
Decision Date2000-06-20
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSUFFLATION NEEDLE- 120MM, MODEL 900-200 is the device name listed in this FDA 510(k) record. The listed applicant is Genicon, LC. It received FDA 510(k) clearance on 2000-06-20 under 510(k) number K993625. 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 INSUFFLATION NEEDLE- 120MM, MODEL 900-200?

INSUFFLATION NEEDLE- 120MM, MODEL 900-200 is a medical device that received FDA 510(k) clearance on 2000-06-20. The listed applicant is Genicon, LC. The 510(k) number is K993625.

When did INSUFFLATION NEEDLE- 120MM, MODEL 900-200 receive FDA 510(k) clearance?

INSUFFLATION NEEDLE- 120MM, MODEL 900-200 received FDA 510(k) clearance on 2000-06-20, under 510(k) number K993625.

Who is the listed applicant for INSUFFLATION NEEDLE- 120MM, MODEL 900-200?

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

What is the FDA product code for INSUFFLATION NEEDLE- 120MM, MODEL 900-200?

The FDA product code for INSUFFLATION NEEDLE- 120MM, MODEL 900-200 is HIF.

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Other records listing Genicon, LC 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.

K030174GENICON LAPAROSCOPESK030269GENICON CLIP APPLIERK002542REUSABLE CANNULAK991382SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101K982472GENICON TROCAR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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