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FDA 510(k)

GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES

K-Number: K012660 · 2001-12-20

ApplicantGimmi GmbH
Decision Date2001-12-20
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Gimmi GmbH. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K012660. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES?

GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Gimmi GmbH. The 510(k) number is K012660.

When did GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES receive FDA 510(k) clearance?

GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES received FDA 510(k) clearance on 2001-12-20, under 510(k) number K012660.

Who is the listed applicant for GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES?

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

What is the FDA product code for GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES?

The FDA product code for GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES is FET.

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Other records listing Gimmi 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.

K261179AlphaTriPart - Monopolar MIC InstrumentsK092421ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTICK093125ALPHAXENON LIGHT 180 W AND 300 WK081640GIMMI ANEURYSM CLIPS AND APPLYING FORCEPSK012869GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25K013731GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03

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Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

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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