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)

INSURGICAL SINGLE USE POWER EQUIPMENT

K-Number: K112599 · 2012-11-06

ApplicantInsurgical, LLC
Decision Date2012-11-06
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INSURGICAL SINGLE USE POWER EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Insurgical, LLC. It received FDA 510(k) clearance on 2012-11-06 under 510(k) number K112599. The device is classified under product code KIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSURGICAL SINGLE USE POWER EQUIPMENT?

INSURGICAL SINGLE USE POWER EQUIPMENT is a medical device that received FDA 510(k) clearance on 2012-11-06. The listed applicant is Insurgical, LLC. The 510(k) number is K112599.

When did INSURGICAL SINGLE USE POWER EQUIPMENT receive FDA 510(k) clearance?

INSURGICAL SINGLE USE POWER EQUIPMENT received FDA 510(k) clearance on 2012-11-06, under 510(k) number K112599.

Who is the listed applicant for INSURGICAL SINGLE USE POWER EQUIPMENT?

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

What is the FDA product code for INSURGICAL SINGLE USE POWER EQUIPMENT?

The FDA product code for INSURGICAL SINGLE USE POWER EQUIPMENT is KIJ.

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: KIJ)

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.

K163308SMARTOJeil Medical CorporationK101563SMARTOJeil Medical CorporationK972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTStryker InstrumentsK970378STRYKER 2115 REPLACEMENT BATTERY (2115)Implant Resource, Inc.K960711ACUMED BONE GRAFT SYSTEMAcu Med, Inc.K951450SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERYStrenumed, 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.

↑