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FDA 510(k)

Endotics

K-Number: K190669 · 2020-01-03

ApplicantEra Endoscopy S.R.L.
Decision Date2020-01-03
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endotics is the device name listed in this FDA 510(k) record. The listed applicant is Era Endoscopy S.R.L.. It received FDA 510(k) clearance on 2020-01-03 under 510(k) number K190669. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endotics?

Endotics is a medical device that received FDA 510(k) clearance on 2020-01-03. The listed applicant is Era Endoscopy S.R.L.. The 510(k) number is K190669.

When did Endotics receive FDA 510(k) clearance?

Endotics received FDA 510(k) clearance on 2020-01-03, under 510(k) number K190669.

Who is the listed applicant for Endotics?

The FDA 510(k) record lists Era Endoscopy S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endotics?

The FDA product code for Endotics is FDF.

Related Devices (Code: FDF)

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.

K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFujifilm CorporationK250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)Olympus Medical Systems Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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