Standard Clamp— 510(k) K153358

Substantially Equivalent

Standard Bariatrics

FDA 510(k) clearance K153358 for Standard Clamp, Substantially Equivalent on 2016-05-02. Applicant: Standard Bariatrics. Device class: 1.

Clearance details

Applicant: Standard Bariatrics
Product code: Code GDJ
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2015-11-20
Decision date: 2016-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDJ

K930315 — THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE1994-02-04
K924223 — MAR-MED LIVER STRAP1993-03-18
K922659 — GENERAL SURGERY CLAMP AND NEEDLE HOLDER1992-07-21
K914913 — GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST1991-12-31
K900956 — GS-7100 CHOLANGIOGRAM CLAMP, 5MM1990-04-18

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K191885 — Standard Bougie2020-04-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.