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FDA 510(k)

PNEUMOPERITONEUM INSUFFLATION NEEDLE

K-Number: K021247 · 2002-11-08

ApplicantMectra Labs, Inc.
Decision Date2002-11-08
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PNEUMOPERITONEUM INSUFFLATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Mectra Labs, Inc.. It received FDA 510(k) clearance on 2002-11-08 under 510(k) number K021247. 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 PNEUMOPERITONEUM INSUFFLATION NEEDLE?

PNEUMOPERITONEUM INSUFFLATION NEEDLE is a medical device that received FDA 510(k) clearance on 2002-11-08. The listed applicant is Mectra Labs, Inc.. The 510(k) number is K021247.

When did PNEUMOPERITONEUM INSUFFLATION NEEDLE receive FDA 510(k) clearance?

PNEUMOPERITONEUM INSUFFLATION NEEDLE received FDA 510(k) clearance on 2002-11-08, under 510(k) number K021247.

Who is the listed applicant for PNEUMOPERITONEUM INSUFFLATION NEEDLE?

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

What is the FDA product code for PNEUMOPERITONEUM INSUFFLATION NEEDLE?

The FDA product code for PNEUMOPERITONEUM INSUFFLATION NEEDLE is HIF.

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Other records listing Mectra Labs, Inc. as applicant

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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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