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FDA 510(k)

COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON

K-Number: K061937 · 2006-12-01

ApplicantCook Endoscopy
Decision Date2006-12-01
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Cook Endoscopy. It received FDA 510(k) clearance on 2006-12-01 under 510(k) number K061937. The device is classified under product code KNQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON?

COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON is a medical device that received FDA 510(k) clearance on 2006-12-01. The listed applicant is Cook Endoscopy. The 510(k) number is K061937.

When did COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON receive FDA 510(k) clearance?

COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON received FDA 510(k) clearance on 2006-12-01, under 510(k) number K061937.

Who is the listed applicant for COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON?

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

What is the FDA product code for COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON?

The FDA product code for COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON is KNQ.

Related Clinical Trials

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.

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Other records listing Cook Endoscopy 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.

K192697Instinct Plus Endoscopic Clipping DeviceK090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONK083330ECHOTIP ULTRA ULTRASOUND NEEDLE

Related Devices (Code: KNQ)

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.

K122924CRE FIXED WIRE BALLON DILATION CATHETERBoston Scientific CorpK093236ETHICON ENDO-SURGERYOPTICAL DILATOREthicon Endo-Surgery, Inc.K090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONCook EndoscopyK082995SMART DILATORSafestitch MedicalK061787MAXFORCE TTS SINGLE-USE BALLOON DILATORBoston Scientific CorpK060302INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDEDCordis Europa, N.V.

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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