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FDA 510(k)

MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM

K-Number: K111480 · 2012-04-04

ApplicantTechnology Delivery Systems, Inc.
Decision Date2012-04-04
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM is the device name listed in this FDA 510(k) record. The listed applicant is Technology Delivery Systems, Inc.. It received FDA 510(k) clearance on 2012-04-04 under 510(k) number K111480. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM?

MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM is a medical device that received FDA 510(k) clearance on 2012-04-04. The listed applicant is Technology Delivery Systems, Inc.. The 510(k) number is K111480.

When did MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM receive FDA 510(k) clearance?

MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM received FDA 510(k) clearance on 2012-04-04, under 510(k) number K111480.

Who is the listed applicant for MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM?

The FDA 510(k) record lists Technology Delivery Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM?

The FDA product code for MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM is FGB.

Related Clinical Trials

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.

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Other records listing Technology Delivery Systems, Inc. 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.

K062725MAXIFLEX-SEMI FLEX SCOPEK013300MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM

Related Devices (Code: FGB)

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.

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific CorporationK262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.

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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