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FDA 510(k)

ENDOLAP INSUFFLATOR TUBING SET

K-Number: K950219 · 1995-03-23

ApplicantEndolap, Inc.
Decision Date1995-03-23
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOLAP INSUFFLATOR TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Endolap, Inc.. It received FDA 510(k) clearance on 1995-03-23 under 510(k) number K950219. 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 ENDOLAP INSUFFLATOR TUBING SET?

ENDOLAP INSUFFLATOR TUBING SET is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Endolap, Inc.. The 510(k) number is K950219.

When did ENDOLAP INSUFFLATOR TUBING SET receive FDA 510(k) clearance?

ENDOLAP INSUFFLATOR TUBING SET received FDA 510(k) clearance on 1995-03-23, under 510(k) number K950219.

Who is the listed applicant for ENDOLAP INSUFFLATOR TUBING SET?

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

What is the FDA product code for ENDOLAP INSUFFLATOR TUBING SET?

The FDA product code for ENDOLAP INSUFFLATOR TUBING SET 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.

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Other records listing Endolap, 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.

K974516ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODEK974515ENDOLAP RESECTOSCOPE ROLLER ELECTRODEK950243TITAN INSUFFLATION NEEDLEK933492ESYS SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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