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FDA 510(k)

PROXIDERM, MODELS TN 460, TN 90 460, BK 460

K-Number: K982439 · 1998-09-08

ApplicantProgressive Surgical Products, Inc.
Decision Date1998-09-08
Product CodeMKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROXIDERM, MODELS TN 460, TN 90 460, BK 460 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 1998-09-08 under 510(k) number K982439. 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, MODELS TN 460, TN 90 460, BK 460?

PROXIDERM, MODELS TN 460, TN 90 460, BK 460 is a medical device that received FDA 510(k) clearance on 1998-09-08. The listed applicant is Progressive Surgical Products, Inc.. The 510(k) number is K982439.

When did PROXIDERM, MODELS TN 460, TN 90 460, BK 460 receive FDA 510(k) clearance?

PROXIDERM, MODELS TN 460, TN 90 460, BK 460 received FDA 510(k) clearance on 1998-09-08, under 510(k) number K982439.

Who is the listed applicant for PROXIDERM, MODELS TN 460, TN 90 460, BK 460?

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, MODELS TN 460, TN 90 460, BK 460?

The FDA product code for PROXIDERM, MODELS TN 460, TN 90 460, BK 460 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.

K970439PROXIDERM (D-460,D 90 460,D 180,460, PS 460)K942425PROXIDERM (TENTATIVE)

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.K970439PROXIDERM (D-460,D 90 460,D 180,460, PS 460)Progressive Surgical Products, Inc.K962144PHOENIX ETE TISSUE EXTENSION SYSTEMPhoenix Biomedical Corp.K942425PROXIDERM (TENTATIVE)Progressive Surgical Products, Inc.K942526SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEMLife Medical Sciences, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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