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FDA 510(k)

ACMI M4 TELESCOPES

K-Number: K031758 · 2003-09-02

ApplicantAcmi Corporation
Decision Date2003-09-02
Product CodeFBP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACMI M4 TELESCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Acmi Corporation. It received FDA 510(k) clearance on 2003-09-02 under 510(k) number K031758. The device is classified under product code FBP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACMI M4 TELESCOPES?

ACMI M4 TELESCOPES is a medical device that received FDA 510(k) clearance on 2003-09-02. The listed applicant is Acmi Corporation. The 510(k) number is K031758.

When did ACMI M4 TELESCOPES receive FDA 510(k) clearance?

ACMI M4 TELESCOPES received FDA 510(k) clearance on 2003-09-02, under 510(k) number K031758.

Who is the listed applicant for ACMI M4 TELESCOPES?

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

What is the FDA product code for ACMI M4 TELESCOPES?

The FDA product code for ACMI M4 TELESCOPES is FBP.

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Other records listing Acmi Corporation 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.

K061975PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PKK060752ACMI DUR-HL LASER SYSTEMSK060269ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEMK051593UROPASS URETERAL ACCESS SHEATH, MODEL 61224K052044ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6ALK043581DUAL LUMEN CATHETER

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Related Devices (Code: FBP)

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.

K113062ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICESEndoservice Optical Instruments GmbHK984607PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXXRichard Wolf Medical Instruments Corp.K760177TELESCOPE, RIGID ENDOSCOPEV. Mueller O.V. Baxter Healthcare Corp.

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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