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FDA 510(k)

SURGITRON

K-Number: K911461 · 1991-04-25

ApplicantEllman Intl. Mfg., Inc.
Decision Date1991-04-25
Product CodeGCI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITRON is the device name listed in this FDA 510(k) record. The listed applicant is Ellman Intl. Mfg., Inc.. It received FDA 510(k) clearance on 1991-04-25 under 510(k) number K911461. The device is classified under product code GCI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITRON?

SURGITRON is a medical device that received FDA 510(k) clearance on 1991-04-25. The listed applicant is Ellman Intl. Mfg., Inc.. The 510(k) number is K911461.

When did SURGITRON receive FDA 510(k) clearance?

SURGITRON received FDA 510(k) clearance on 1991-04-25, under 510(k) number K911461.

Who is the listed applicant for SURGITRON?

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

What is the FDA product code for SURGITRON?

The FDA product code for SURGITRON is GCI.

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 Ellman Intl. Mfg., 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.

K914329SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION

Related Devices (Code: GCI)

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.

K021747DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTORSurgicon, Inc.K003222MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTERComputer Motion, Inc.K001362KARL STORZ 3D VIDEO SYSTEMKarl Storz Imaging, Inc.K933515BOOTY ENDOSCOPE WARMERT-Med, Inc.K930302BIRTCHER SURE CLEAN INSTRUMENT SYSTEMBirtcher Medical Systems, Inc.K930496GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPSBirtcher Medical Systems, 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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