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)

U-100 BAG

K-Number: K821853 · 1982-07-22

ApplicantMedical Technologies of Georgia
Decision Date1982-07-22
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

U-100 BAG is the device name listed in this FDA 510(k) record. The listed applicant is Medical Technologies of Georgia. It received FDA 510(k) clearance on 1982-07-22 under 510(k) number K821853. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-100 BAG?

U-100 BAG is a medical device that received FDA 510(k) clearance on 1982-07-22. The listed applicant is Medical Technologies of Georgia. The 510(k) number is K821853.

When did U-100 BAG receive FDA 510(k) clearance?

U-100 BAG received FDA 510(k) clearance on 1982-07-22, under 510(k) number K821853.

Who is the listed applicant for U-100 BAG?

The FDA 510(k) record lists Medical Technologies of Georgia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-100 BAG?

The FDA product code for U-100 BAG is KNX.

Other records listing Medical Technologies of Georgia 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.

K973120READYCATH CATHETERK952392MLI SETK911129MMG BILE BAGK873136MMG CATH-N-PLACEK871949MMG DELEE SUCTION CATHETER W/MUCOUS TRAPK854821MMG EXTERNAL FEMALE CATHETERS

View all 12 devices →

Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

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.

↑