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FDA 510(k)

Standard Bougie, 38 Fr. and Hand Pump

K-Number: K212728 · 2021-09-23

ApplicantStandard Bariatrics
Decision Date2021-09-23
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Standard Bougie, 38 Fr. and Hand Pump is the device name listed in this FDA 510(k) record. The listed applicant is Standard Bariatrics. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K212728. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Standard Bougie, 38 Fr. and Hand Pump?

Standard Bougie, 38 Fr. and Hand Pump is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Standard Bariatrics. The 510(k) number is K212728.

When did Standard Bougie, 38 Fr. and Hand Pump receive FDA 510(k) clearance?

Standard Bougie, 38 Fr. and Hand Pump received FDA 510(k) clearance on 2021-09-23, under 510(k) number K212728.

Who is the listed applicant for Standard Bougie, 38 Fr. and Hand Pump?

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

What is the FDA product code for Standard Bougie, 38 Fr. and Hand Pump?

The FDA product code for Standard Bougie, 38 Fr. and Hand Pump is KNT.

Other records listing Standard Bariatrics 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.

K231603Standard Staple-Line Reinforcement (SSLR23)K222085Standard Tapered Bougie, 38 Fr.K210437Standard Bougie, 38 Fr.K210278Titan SGSK200517Standard TrocarK191885Standard Bougie

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Related Devices (Code: KNT)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota 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.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ 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

Official Source

View on FDA Database →

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

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