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FDA 510(k)

INSUFFLATION TUBING

K-Number: K925691 · 1993-09-23

ApplicantMectra Labs, Inc.
Decision Date1993-09-23
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSUFFLATION TUBING 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 1993-09-23 under 510(k) number K925691. 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 INSUFFLATION TUBING?

INSUFFLATION TUBING is a medical device that received FDA 510(k) clearance on 1993-09-23. The listed applicant is Mectra Labs, Inc.. The 510(k) number is K925691.

When did INSUFFLATION TUBING receive FDA 510(k) clearance?

INSUFFLATION TUBING received FDA 510(k) clearance on 1993-09-23, under 510(k) number K925691.

Who is the listed applicant for INSUFFLATION TUBING?

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 INSUFFLATION TUBING?

The FDA product code for INSUFFLATION TUBING is HIF.

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Other records listing Mectra Labs, 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.

K113080TUBALGATORK033880ELECTRO-LUBEK021247PNEUMOPERITONEUM INSUFFLATION NEEDLEK993604ENDOSCOPIC ANTI FOG DEVICEK955352SUCTION CAUTERY PROBEK934547MECTRA TROCAR

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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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