FDA 510(k)

Lap-Band System Calibration Tube

Número K: K220455 · 2022-06-07

Data da decisão2022-06-07

Código do produtoKNT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lap-Band System Calibration Tube is the device name listed in this FDA 510(k) record. The listed applicant is Reshape Lifesciences. It received FDA 510(k) clearance on 2022-06-07 under 510(k) number K220455. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lap-Band System Calibration Tube?

Lap-Band System Calibration Tube is a medical device that received FDA 510(k) clearance on 2022-06-07. The listed applicant is Reshape Lifesciences. The 510(k) number is K220455.

When did Lap-Band System Calibration Tube receive FDA 510(k) clearance?

Lap-Band System Calibration Tube received FDA 510(k) clearance on 2022-06-07, under 510(k) number K220455.

Who is the listed applicant for Lap-Band System Calibration Tube?

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 Lap-Band System Calibration Tube?

The FDA product code for Lap-Band System Calibration Tube is KNT.

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Outros registros que listam Reshape Lifesciences como candidato(a)

K241039ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)K230131ReShape Calibration Tubes K221898Gastrointestinal Boundary Identifier (GIBI HD)

Dispositivos Relacionados (Código: 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

Fonte oficial

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