FDA 510(k)

Gastrointestinal Boundary Identifier (GIBI HD)

K-번호: K221898 · 2022-07-28

결정일2022-07-28

제품 코드KNT

자문 위원회GU

결정Substantially Equivalent

기기 요약

Gastrointestinal Boundary Identifier (GIBI HD) is the device name listed in this FDA 510(k) record. The listed applicant is Reshape Lifesciences. It received FDA 510(k) clearance on 2022-07-28 under 510(k) number K221898. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Gastrointestinal Boundary Identifier (GIBI HD)?

Gastrointestinal Boundary Identifier (GIBI HD) is a medical device that received FDA 510(k) clearance on 2022-07-28. The listed applicant is Reshape Lifesciences. The 510(k) number is K221898.

When did Gastrointestinal Boundary Identifier (GIBI HD) receive FDA 510(k) clearance?

Gastrointestinal Boundary Identifier (GIBI HD) received FDA 510(k) clearance on 2022-07-28, under 510(k) number K221898.

Who is the listed applicant for Gastrointestinal Boundary Identifier (GIBI HD)?

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

What is the FDA product code for Gastrointestinal Boundary Identifier (GIBI HD)?

The FDA product code for Gastrointestinal Boundary Identifier (GIBI HD) is KNT.

Reshape Lifesciences를 신청인으로 등재한 기타 기록

K241039ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)K230131ReShape Calibration Tubes K220455Lap-Band System Calibration Tube

관련 기기 (코드: KNT)

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd K243228Flexi-Seal AIR (with ENFit Connector)Convatec K242336hygh-tec Drainage IIAmb Medtec K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

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