胃光纤（GLG）
K号: K212407 · 2022-07-26
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决定日期2022-07-26
产品代码KNT
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
Gastric Lightguide (GLG) is the device name listed in this FDA 510(k) record. The listed applicant is Naser Dib Gabinet Lekarksi Nasmed. It received FDA 510(k) clearance on 2022-07-26 under 510(k) number K212407. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Gastric Lightguide (GLG)?
Gastric Lightguide (GLG) is a medical device that received FDA 510(k) clearance on 2022-07-26. The listed applicant is Naser Dib Gabinet Lekarksi Nasmed. The 510(k) number is K212407.
When did Gastric Lightguide (GLG) receive FDA 510(k) clearance?
Gastric Lightguide (GLG) received FDA 510(k) clearance on 2022-07-26, under 510(k) number K212407.
Who is the listed applicant for Gastric Lightguide (GLG)?
The FDA 510(k) record lists Naser Dib Gabinet Lekarksi Nasmed as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Gastric Lightguide (GLG)?
The FDA product code for Gastric Lightguide (GLG) is KNT.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：KNT）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K26189052Fr ViSiGi LUX™；52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514明尼苏达四腔食管胃填塞管 - 18 French (0092220)；布莱克莫尔食管鼻胃管 - 20 French (0092100)；布莱克莫尔食管鼻胃管 - 16 French (0092300)C.R. Bard, Inc.K250389XNY一次性胃腔校准管Changzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR（带 ENFit 连接器）ConvatecK242336hygh-tec 排液IIAmb MedtecK242901ZZIREN™ 口胃管；ZZIREN™ SGT 口胃管 - 32 Fr（ZZ-SGT-32）；ZZIREN™ SGT 口胃管 - 36 Fr（ZZ-SGT-36）；ZZIREN™ SGT 口胃管 - 40 Fr（ZZ-SGT-40）；ZZIREN™ GBT 口胃管 - 32 Fr（ZZ-GBT-32）；ZZIREN™ GBT 口胃管 - 36 Fr（ZZ-GBT-36）；ZZIREN™ GBT 口胃管 - 40 Fr（ZZ-GBT-40）Tools For Surgery, LLC
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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