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)

GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.

K-Number: K933300 · 1994-09-30

ApplicantLyle Howard Corp.
Decision Date1994-09-30
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. is the device name listed in this FDA 510(k) record. The listed applicant is Lyle Howard Corp.. It received FDA 510(k) clearance on 1994-09-30 under 510(k) number K933300. The device is classified under product code KNF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.?

GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. is a medical device that received FDA 510(k) clearance on 1994-09-30. The listed applicant is Lyle Howard Corp.. The 510(k) number is K933300.

When did GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. receive FDA 510(k) clearance?

GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. received FDA 510(k) clearance on 1994-09-30, under 510(k) number K933300.

Who is the listed applicant for GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.?

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

What is the FDA product code for GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.?

The FDA product code for GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. is KNF.

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

Related Devices (Code: KNF)

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.

K254303KARL STORZ SUPRALOOPKarl Storz SE & CO. KGK250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, 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.

↑