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FDA 510(k)

NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

K-Number: K102616 · 2010-12-30

ApplicantSmart Medical Systems , Ltd.
Decision Date2010-12-30
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Smart Medical Systems , Ltd.. It received FDA 510(k) clearance on 2010-12-30 under 510(k) number K102616. 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 NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE?

NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE is a medical device that received FDA 510(k) clearance on 2010-12-30. The listed applicant is Smart Medical Systems , Ltd.. The 510(k) number is K102616.

When did NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE receive FDA 510(k) clearance?

NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE received FDA 510(k) clearance on 2010-12-30, under 510(k) number K102616.

Who is the listed applicant for NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE?

The FDA 510(k) record lists Smart Medical Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE?

The FDA product code for NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE is FDF.

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Other records listing Smart Medical Systems , Ltd. 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.

K220158G-EYE SystemK202469G-EYE SystemK192588G-EYE SystemK112106NAVIAID ICVI-F,S,B,R DEVICEK111760NAVIAID(TM) BGC DEVICEK110291NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE

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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.

K260503Triton 1 SystemNeptune Medical, Inc.K261015Solo Scope Colonoscope SystemGi View, Ltd.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.

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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