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FDA 510(k)

ONE STEP BUTTON(TM)

K-Number: K910584 · 1991-05-23

ApplicantApplied Medical Technologies
Decision Date1991-05-23
Product CodeKGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ONE STEP BUTTON(TM) 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 1991-05-23 under 510(k) number K910584. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE STEP BUTTON(TM)?

ONE STEP BUTTON(TM) is a medical device that received FDA 510(k) clearance on 1991-05-23. The listed applicant is Applied Medical Technologies. The 510(k) number is K910584.

When did ONE STEP BUTTON(TM) receive FDA 510(k) clearance?

ONE STEP BUTTON(TM) received FDA 510(k) clearance on 1991-05-23, under 510(k) number K910584.

Who is the listed applicant for ONE STEP BUTTON(TM)?

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 ONE STEP BUTTON(TM)?

The FDA product code for ONE STEP BUTTON(TM) is KGC.

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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 ACCESSORIESK973893AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAEK971757LOW PROFILE FEEDING SET ACCESSORYK971758CAUTERIZATION SMOKE EVACUATORK961345DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE

View all 23 devices →

Related Devices (Code: KGC)

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.

K242211PUMA-G Pediatric SystemCoaptech, Inc.K223916PUMA-G SystemCoaptech, Inc.K193612AMT Suture Delivery SystemApplied Medical Technology, Inc.K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd.K182832Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetCook IncorporatedK183057PUMA-G SystemCoaptech, 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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