Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODEL AU-1 ACCESSORY UNIT

K-Number: K882926 · 1988-09-09

ApplicantDirected Energy, Inc.
Decision Date1988-09-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL AU-1 ACCESSORY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Directed Energy, Inc.. It received FDA 510(k) clearance on 1988-09-09 under 510(k) number K882926. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL AU-1 ACCESSORY UNIT?

MODEL AU-1 ACCESSORY UNIT is a medical device that received FDA 510(k) clearance on 1988-09-09. The listed applicant is Directed Energy, Inc.. The 510(k) number is K882926.

When did MODEL AU-1 ACCESSORY UNIT receive FDA 510(k) clearance?

MODEL AU-1 ACCESSORY UNIT received FDA 510(k) clearance on 1988-09-09, under 510(k) number K882926.

Who is the listed applicant for MODEL AU-1 ACCESSORY UNIT?

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

What is the FDA product code for MODEL AU-1 ACCESSORY UNIT?

The FDA product code for MODEL AU-1 ACCESSORY UNIT is GEX. This falls under the Gastroenterology category.

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 Directed Energy, 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.

K904930SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CHK894241MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENTK883738CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.K880216MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.K873331ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURGK872709MODEL 20-C, RL-20A/U, OB-10A/U

View all 39 devices →

Related Devices (Code: GEX)

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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.

↑