FDA 510(k)

INSUFFLATOR, MODEL G100 & 200

K-Number: K772297 · 1978-01-05

ApplicantKli

Decision Date1978-01-05

Product CodeHIF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

INSUFFLATOR, MODEL G100 & 200 is the device name listed in this FDA 510(k) record. The listed applicant is Kli. It received FDA 510(k) clearance on 1978-01-05 under 510(k) number K772297. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSUFFLATOR, MODEL G100 & 200?

INSUFFLATOR, MODEL G100 & 200 is a medical device that received FDA 510(k) clearance on 1978-01-05. The listed applicant is Kli. The 510(k) number is K772297.

When did INSUFFLATOR, MODEL G100 & 200 receive FDA 510(k) clearance?

INSUFFLATOR, MODEL G100 & 200 received FDA 510(k) clearance on 1978-01-05, under 510(k) number K772297.

Who is the listed applicant for INSUFFLATOR, MODEL G100 & 200?

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

What is the FDA product code for INSUFFLATOR, MODEL G100 & 200?

The FDA product code for INSUFFLATOR, MODEL G100 & 200 is HIF.

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 Kli as applicant

K800822CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE K800913GYNECOLOGICAL CYSTO/URETHROSCOPE K781913INSUFFALATOR LAPARAOSCOPIC K781109FORCEPS, ELECTROSURGICAL K781089ONE INCISION BI-POLAR ELECTRO. FORCEPS K780955SCISSORS, HOOK, ELECTROSURGICAL

View all 18 devices →

Related Devices (Code: HIF)

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KG K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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.