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FDA 510(k)

REFLEX INS INSUFFLATION NEEDLE

K-Number: K942207 · 1994-05-27

ApplicantRichard-Allan Medical
Decision Date1994-05-27
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

REFLEX INS INSUFFLATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Richard-Allan Medical. It received FDA 510(k) clearance on 1994-05-27 under 510(k) number K942207. 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 REFLEX INS INSUFFLATION NEEDLE?

REFLEX INS INSUFFLATION NEEDLE is a medical device that received FDA 510(k) clearance on 1994-05-27. The listed applicant is Richard-Allan Medical. The 510(k) number is K942207.

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

REFLEX INS INSUFFLATION NEEDLE received FDA 510(k) clearance on 1994-05-27, under 510(k) number K942207.

Who is the listed applicant for REFLEX INS INSUFFLATION NEEDLE?

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

What is the FDA product code for REFLEX INS INSUFFLATION NEEDLE?

The FDA product code for REFLEX INS INSUFFLATION NEEDLE is HIF.

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Other records listing Richard-Allan 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.

K935105REFLEX ESP WITH FINGER SWITCHESK933508REFLEX SDD SURGICAL STAPLERK933901REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)K924881REFLEX(R) ESPK924929REFLEX(R) ECAK905701RICHARD-ALLAN SHEET CLIP

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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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