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)

PROXIDERM (TENTATIVE)

K-Number: K942425 · 1994-11-04

ApplicantProgressive Surgical Products, Inc.
Decision Date1994-11-04
Product CodeMKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROXIDERM (TENTATIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Progressive Surgical Products, Inc.. It received FDA 510(k) clearance on 1994-11-04 under 510(k) number K942425. The device is classified under product code MKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROXIDERM (TENTATIVE)?

PROXIDERM (TENTATIVE) is a medical device that received FDA 510(k) clearance on 1994-11-04. The listed applicant is Progressive Surgical Products, Inc.. The 510(k) number is K942425.

When did PROXIDERM (TENTATIVE) receive FDA 510(k) clearance?

PROXIDERM (TENTATIVE) received FDA 510(k) clearance on 1994-11-04, under 510(k) number K942425.

Who is the listed applicant for PROXIDERM (TENTATIVE)?

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

What is the FDA product code for PROXIDERM (TENTATIVE)?

The FDA product code for PROXIDERM (TENTATIVE) is MKY.

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 Progressive Surgical Products, 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.

K982439PROXIDERM, MODELS TN 460, TN 90 460, BK 460K970439PROXIDERM (D-460,D 90 460,D 180,460, PS 460)

Related Devices (Code: MKY)

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.

K002315WISEBANDS SKIN CLOSURE DEVICEWisebands , Ltd.K982439PROXIDERM, MODELS TN 460, TN 90 460, BK 460Progressive Surgical Products, Inc.K970439PROXIDERM (D-460,D 90 460,D 180,460, PS 460)Progressive Surgical Products, Inc.K962144PHOENIX ETE TISSUE EXTENSION SYSTEMPhoenix Biomedical Corp.K942526SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEMLife Medical Sciences, 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.

↑