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FDA 510(k)

AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE

K-Number: K973893 · 1997-12-19

ApplicantApplied Medical Technologies
Decision Date1997-12-19
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technologies. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K973893. 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 AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE?

AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Applied Medical Technologies. The 510(k) number is K973893.

When did AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE receive FDA 510(k) clearance?

AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE received FDA 510(k) clearance on 1997-12-19, under 510(k) number K973893.

Who is the listed applicant for AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE?

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

What is the FDA product code for AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE?

The FDA product code for AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE is KNT.

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Other records listing Applied Medical Technologies 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.

K971434A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICEK972478PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIESK971757LOW PROFILE FEEDING SET ACCESSORYK971758CAUTERIZATION SMOKE EVACUATORK961345DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBEK960232ENDOSCOPIC ACCESS DEVICE

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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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