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FDA 510(k)

KSEA CO2 ENDOFLATOR

K-Number: K963423 · 1997-05-27

ApplicantKarl Storz Endoscopy
Decision Date1997-05-27
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KSEA CO2 ENDOFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 1997-05-27 under 510(k) number K963423. 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 KSEA CO2 ENDOFLATOR?

KSEA CO2 ENDOFLATOR is a medical device that received FDA 510(k) clearance on 1997-05-27. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K963423.

When did KSEA CO2 ENDOFLATOR receive FDA 510(k) clearance?

KSEA CO2 ENDOFLATOR received FDA 510(k) clearance on 1997-05-27, under 510(k) number K963423.

Who is the listed applicant for KSEA CO2 ENDOFLATOR?

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

What is the FDA product code for KSEA CO2 ENDOFLATOR?

The FDA product code for KSEA CO2 ENDOFLATOR is HIF.

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Other records listing Karl Storz Endoscopy 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.

K043375FISCH TITANIUM MIDDLE EAR PROSTHESESK030848PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIXK030009KSEA POWERSHAVER SYSTEM S2K023924AUTOCON II 200 ELECTROSURGICAL GENERATORK023187KSEA SPINOSCOPEK011700MODULITH SLK LITHOTRIPTER

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Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (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. KGK242772AirSurgN 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.

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