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)

Flexible Overtube

K-Number: K182520 · 2019-05-15

ApplicantSumitomo Bakelite Co., Ltd.
Decision Date2019-05-15
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Overtube is the device name listed in this FDA 510(k) record. The listed applicant is Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K182520. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexible Overtube?

Flexible Overtube is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is Sumitomo Bakelite Co., Ltd.. The 510(k) number is K182520.

When did Flexible Overtube receive FDA 510(k) clearance?

Flexible Overtube received FDA 510(k) clearance on 2019-05-15, under 510(k) number K182520.

Who is the listed applicant for Flexible Overtube?

The FDA 510(k) record lists Sumitomo Bakelite Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Overtube?

The FDA product code for Flexible Overtube is FED.

Other records listing Sumitomo Bakelite Co., 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.

K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - LongK173004SB Soft Hood - Straight type, SB Soft Hood - Undercut typeK152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long

Related Devices (Code: FED)

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.

K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development 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.

↑