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FDA 510(k)

UNIDRIVE II PLUS DISPOSABLE TUBING SET

K-Number: K021811 · 2002-06-19

ApplicantMtp Medical Technical Promotion GmbH
Decision Date2002-06-19
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

UNIDRIVE II PLUS DISPOSABLE TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Mtp Medical Technical Promotion GmbH. It received FDA 510(k) clearance on 2002-06-19 under 510(k) number K021811. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIDRIVE II PLUS DISPOSABLE TUBING SET?

UNIDRIVE II PLUS DISPOSABLE TUBING SET is a medical device that received FDA 510(k) clearance on 2002-06-19. The listed applicant is Mtp Medical Technical Promotion GmbH. The 510(k) number is K021811.

When did UNIDRIVE II PLUS DISPOSABLE TUBING SET receive FDA 510(k) clearance?

UNIDRIVE II PLUS DISPOSABLE TUBING SET received FDA 510(k) clearance on 2002-06-19, under 510(k) number K021811.

Who is the listed applicant for UNIDRIVE II PLUS DISPOSABLE TUBING SET?

The FDA 510(k) record lists Mtp Medical Technical Promotion GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIDRIVE II PLUS DISPOSABLE TUBING SET?

The FDA product code for UNIDRIVE II PLUS DISPOSABLE TUBING SET is ERL.

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Other records listing Mtp Medical Technical Promotion GmbH 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.

K091178MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREENK020599MTP CLEARVISION DISPOSABLE TUBING SETK011360MTP LAPAROMAT DISPOSABLE TUBING SETK000337MTP DISPOSABLE TROCAR VALVESK994066MTP DISPOSABLE TROCARSK990912MTP EXTRACTION BAG

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Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker 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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