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)

DERMIDRESS

K-Number: K844463 · 1985-01-08

ApplicantKells Medical, Inc.
Decision Date1985-01-08
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMIDRESS is the device name listed in this FDA 510(k) record. The listed applicant is Kells Medical, Inc.. It received FDA 510(k) clearance on 1985-01-08 under 510(k) number K844463. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMIDRESS?

DERMIDRESS is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Kells Medical, Inc.. The 510(k) number is K844463.

When did DERMIDRESS receive FDA 510(k) clearance?

DERMIDRESS received FDA 510(k) clearance on 1985-01-08, under 510(k) number K844463.

Who is the listed applicant for DERMIDRESS?

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

What is the FDA product code for DERMIDRESS?

The FDA product code for DERMIDRESS is KGX.

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 Kells Medical, 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.

K926333CPR PLUSK890093PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SETK890094EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK890095PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK861972DERMISTRIPK844072DERMIZIP SKIN CLOSURE DEVICE

View all 12 devices →

Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, 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.

↑