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)

AQUA-GEL

K-Number: K781032 · 1978-12-15

ApplicantMurray, Salk, Inc.
Decision Date1978-12-15
Product CodeEXQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AQUA-GEL is the device name listed in this FDA 510(k) record. The listed applicant is Murray, Salk, Inc.. It received FDA 510(k) clearance on 1978-12-15 under 510(k) number K781032. The device is classified under product code EXQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUA-GEL?

AQUA-GEL is a medical device that received FDA 510(k) clearance on 1978-12-15. The listed applicant is Murray, Salk, Inc.. The 510(k) number is K781032.

When did AQUA-GEL receive FDA 510(k) clearance?

AQUA-GEL received FDA 510(k) clearance on 1978-12-15, under 510(k) number K781032.

Who is the listed applicant for AQUA-GEL?

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

What is the FDA product code for AQUA-GEL?

The FDA product code for AQUA-GEL is EXQ.

Related Devices (Code: EXQ)

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.

K253537Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)Bright Uro, Inc.K243052Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))Bright Uro, Inc.K931282VOLUME TRANSDUCERLife-Tech Intl., Inc.K931574ADVANCE MODEL UDS-ADVLaborie Medical Technologies, Ltd.K920574CAMSYS 6300F.M. Wiest USA, Inc.K880391DACOMED CYSTOMETERDacomed Corp.

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.

↑