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)

FUNS-10, FUNS-11

K-Number: K862551 · 1986-09-12

ApplicantReichert-Jung, Inc.
Decision Date1986-09-12
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUNS-10, FUNS-11 is the device name listed in this FDA 510(k) record. The listed applicant is Reichert-Jung, Inc.. It received FDA 510(k) clearance on 1986-09-12 under 510(k) number K862551. 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 FUNS-10, FUNS-11?

FUNS-10, FUNS-11 is a medical device that received FDA 510(k) clearance on 1986-09-12. The listed applicant is Reichert-Jung, Inc.. The 510(k) number is K862551.

When did FUNS-10, FUNS-11 receive FDA 510(k) clearance?

FUNS-10, FUNS-11 received FDA 510(k) clearance on 1986-09-12, under 510(k) number K862551.

Who is the listed applicant for FUNS-10, FUNS-11?

The FDA 510(k) record lists Reichert-Jung, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUNS-10, FUNS-11?

The FDA product code for FUNS-10, FUNS-11 is FGB.

Other records listing Reichert-Jung, 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.

K864821AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2K852994REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11

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

View on FDA Database →

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

↑