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FDA 510(k)

MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET

K-Number: K033991 · 2004-01-22

ApplicantPall Medical
Decision Date2004-01-22
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Pall Medical. It received FDA 510(k) clearance on 2004-01-22 under 510(k) number K033991. 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 MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET?

MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET is a medical device that received FDA 510(k) clearance on 2004-01-22. The listed applicant is Pall Medical. The 510(k) number is K033991.

When did MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET receive FDA 510(k) clearance?

MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET received FDA 510(k) clearance on 2004-01-22, under 510(k) number K033991.

Who is the listed applicant for MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET?

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

What is the FDA product code for MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET?

The FDA product code for MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET is HIF.

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Other records listing Pall Medical 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.

K030469LAPAROSHIELD CONDITIONED INSUFFLATION SETK013093PALL ULTIPOR ANESTHESIA BREATHING SYSTEMK992361PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1K983735PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANEK983731PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE

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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