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FDA 510(k)

INSITE MODEL 20 & MODEL 15 INSUFFLATORS

K-Number: K934926 · 1994-05-26

ApplicantAndronic Devices, Ltd.
Decision Date1994-05-26
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSITE MODEL 20 & MODEL 15 INSUFFLATORS is the device name listed in this FDA 510(k) record. The listed applicant is Andronic Devices, Ltd.. It received FDA 510(k) clearance on 1994-05-26 under 510(k) number K934926. 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 INSITE MODEL 20 & MODEL 15 INSUFFLATORS?

INSITE MODEL 20 & MODEL 15 INSUFFLATORS is a medical device that received FDA 510(k) clearance on 1994-05-26. The listed applicant is Andronic Devices, Ltd.. The 510(k) number is K934926.

When did INSITE MODEL 20 & MODEL 15 INSUFFLATORS receive FDA 510(k) clearance?

INSITE MODEL 20 & MODEL 15 INSUFFLATORS received FDA 510(k) clearance on 1994-05-26, under 510(k) number K934926.

Who is the listed applicant for INSITE MODEL 20 & MODEL 15 INSUFFLATORS?

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

What is the FDA product code for INSITE MODEL 20 & MODEL 15 INSUFFLATORS?

The FDA product code for INSITE MODEL 20 & MODEL 15 INSUFFLATORS is HIF.

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Other records listing Andronic Devices, Ltd. 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.

K940812INSIGHT ELECTRONIC ALIGNMENT INDICATORK934928INSITE FILTER & TUBING SETK935381KAPS POSITIONING ARMK934124AUTOQUOT AUTOMATED ALIQUOTTING SYSTEMK936308ENDEX ENDOSCOPIC POSITIONING SYSTEMK932253ARTHROBOT BI-FOLD DRAPE

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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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