Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Insufflation Retention Device

K-Number: K213773 · 2022-07-21

ApplicantBpendo, LLC
Decision Date2022-07-21
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Insufflation Retention Device is the device name listed in this FDA 510(k) record. The listed applicant is Bpendo, LLC. It received FDA 510(k) clearance on 2022-07-21 under 510(k) number K213773. 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 Insufflation Retention Device?

Insufflation Retention Device is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is Bpendo, LLC. The 510(k) number is K213773.

When did Insufflation Retention Device receive FDA 510(k) clearance?

Insufflation Retention Device received FDA 510(k) clearance on 2022-07-21, under 510(k) number K213773.

Who is the listed applicant for Insufflation Retention Device?

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

What is the FDA product code for Insufflation Retention Device?

The FDA product code for Insufflation Retention Device is FDF.

Other records listing Bpendo, LLC 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.

K261587Insufflation Retention Device (IRD) (11173-325-101)

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

View on FDA Database →

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

↑