FDA 510(k)

A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT

K-Number: K914193 · 1992-10-05

Decision Date1992-10-05

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT is the device name listed in this FDA 510(k) record. The listed applicant is Alto Development Corp.. It received FDA 510(k) clearance on 1992-10-05 under 510(k) number K914193. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT?

A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT is a medical device that received FDA 510(k) clearance on 1992-10-05. The listed applicant is Alto Development Corp.. The 510(k) number is K914193.

When did A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT receive FDA 510(k) clearance?

A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT received FDA 510(k) clearance on 1992-10-05, under 510(k) number K914193.

Who is the listed applicant for A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT?

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

What is the FDA product code for A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT?

The FDA product code for A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT is GEI.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alto Development Corp. as applicant

K964621A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON K932513LABELING FOR MYO/WIRE II STERNOTOMY SUTURES K931537A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT K930528A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS K915300A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES K884783RANEY CLIP

View all 10 devices →

Related Devices (Code: GEI)

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL 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.