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)

TOMAC LUBRICATING JELLY

K-Number: K822143 · 1982-07-30

ApplicantAmerican Medical Systems, Inc.
Decision Date1982-07-30
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TOMAC LUBRICATING JELLY is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K822143. The device is classified under product code KMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMAC LUBRICATING JELLY?

TOMAC LUBRICATING JELLY is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K822143.

When did TOMAC LUBRICATING JELLY receive FDA 510(k) clearance?

TOMAC LUBRICATING JELLY received FDA 510(k) clearance on 1982-07-30, under 510(k) number K822143.

Who is the listed applicant for TOMAC LUBRICATING JELLY?

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

What is the FDA product code for TOMAC LUBRICATING JELLY?

The FDA product code for TOMAC LUBRICATING JELLY is KMJ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Medical 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.

K132655RETROARC RETROPUBIC SLING SYSTEMK112842AMS ELEVATE PCK100807MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191K092735GREENLIGHT XPS LASER SYSTEMK090934PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEMK090663AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

View all 72 devices →

Related Devices (Code: KMJ)

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.

K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.K121390LUBE JELLY SURINGENurse Assist, Inc.K113689DUKAL LUBRICATING JELLYDukal CorporationK112110STERILE LUBRICATING JELLYJianerkang Medical Dressing CompanyK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal Corporation

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.

↑