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FDA 510(k)

BALLOON FOR ULTRASONIC ENDOSCOPES

K-Number: K992178 · 2000-05-12

ApplicantN.M. Beale Co., Inc.
Decision Date2000-05-12
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BALLOON FOR ULTRASONIC ENDOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is N.M. Beale Co., Inc.. It received FDA 510(k) clearance on 2000-05-12 under 510(k) number K992178. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALLOON FOR ULTRASONIC ENDOSCOPES?

BALLOON FOR ULTRASONIC ENDOSCOPES is a medical device that received FDA 510(k) clearance on 2000-05-12. The listed applicant is N.M. Beale Co., Inc.. The 510(k) number is K992178.

When did BALLOON FOR ULTRASONIC ENDOSCOPES receive FDA 510(k) clearance?

BALLOON FOR ULTRASONIC ENDOSCOPES received FDA 510(k) clearance on 2000-05-12, under 510(k) number K992178.

Who is the listed applicant for BALLOON FOR ULTRASONIC ENDOSCOPES?

The FDA 510(k) record lists N.M. Beale Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BALLOON FOR ULTRASONIC ENDOSCOPES?

The FDA product code for BALLOON FOR ULTRASONIC ENDOSCOPES is ITX.

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Other records listing N.M. Beale Co., Inc. 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.

K093584EZ-MISTERK093329SCOPE INTRODUCER MODEL 7400K071579PEF TUBEK903834N. M. BEALE COMPANY VU-THRU WATER BOTTLE

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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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