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FDA 510(k)

PROWESS 2000

K-Number: K924240 · 1993-05-17

ApplicantSmall Systems Group, Inc.
Decision Date1993-05-17
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROWESS 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Small Systems Group, Inc.. It received FDA 510(k) clearance on 1993-05-17 under 510(k) number K924240. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROWESS 2000?

PROWESS 2000 is a medical device that received FDA 510(k) clearance on 1993-05-17. The listed applicant is Small Systems Group, Inc.. The 510(k) number is K924240.

When did PROWESS 2000 receive FDA 510(k) clearance?

PROWESS 2000 received FDA 510(k) clearance on 1993-05-17, under 510(k) number K924240.

Who is the listed applicant for PROWESS 2000?

The FDA 510(k) record lists Small Systems Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROWESS 2000?

The FDA product code for PROWESS 2000 is IYE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Small Systems Group, 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.

K884261PROWESS 2000

Related Devices (Code: IYE)

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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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