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FDA 510(k)

HEMISPHERE MULTIPLANE ENDORECTAL PROBE

K-Number: K911043 · 1991-10-09

ApplicantPie Medical Equipment B.V.
Decision Date1991-10-09
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEMISPHERE MULTIPLANE ENDORECTAL PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Equipment B.V.. It received FDA 510(k) clearance on 1991-10-09 under 510(k) number K911043. 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 HEMISPHERE MULTIPLANE ENDORECTAL PROBE?

HEMISPHERE MULTIPLANE ENDORECTAL PROBE is a medical device that received FDA 510(k) clearance on 1991-10-09. The listed applicant is Pie Medical Equipment B.V.. The 510(k) number is K911043.

When did HEMISPHERE MULTIPLANE ENDORECTAL PROBE receive FDA 510(k) clearance?

HEMISPHERE MULTIPLANE ENDORECTAL PROBE received FDA 510(k) clearance on 1991-10-09, under 510(k) number K911043.

Who is the listed applicant for HEMISPHERE MULTIPLANE ENDORECTAL PROBE?

The FDA 510(k) record lists Pie Medical Equipment B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMISPHERE MULTIPLANE ENDORECTAL PROBE?

The FDA product code for HEMISPHERE MULTIPLANE ENDORECTAL PROBE is ITX.

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Other records listing Pie Medical Equipment B.V. 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.

K982203CAAS II LVA BIPLANE OPTIONK945540CAAS IIK915647DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250K912819SC1150 CW/PDK911584DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480K9110447.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)

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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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