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FDA 510(k)

SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR

K-Number: K070783 · 2007-12-13

ApplicantSopro
Decision Date2007-12-13
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sopro. It received FDA 510(k) clearance on 2007-12-13 under 510(k) number K070783. 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 SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR?

SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR is a medical device that received FDA 510(k) clearance on 2007-12-13. The listed applicant is Sopro. The 510(k) number is K070783.

When did SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR receive FDA 510(k) clearance?

SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR received FDA 510(k) clearance on 2007-12-13, under 510(k) number K070783.

Who is the listed applicant for SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR?

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

What is the FDA product code for SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR?

The FDA product code for SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR is HIF.

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Other records listing Sopro 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.

K223470C50K121685SOPROCAREK103813SOPRO 281K092329SOPIX 2K092583SOPROLIFEK082796SOPRO 184 CAMERA

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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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