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FDA 510(k)

PROXIDERM (D-460,D 90 460,D 180,460, PS 460)

K-Number: K970439 · 1997-04-16

ApplicantProgressive Surgical Products, Inc.
Decision Date1997-04-16
Product CodeMKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROXIDERM (D-460,D 90 460,D 180,460, PS 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 1997-04-16 under 510(k) number K970439. 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 (D-460,D 90 460,D 180,460, PS 460)?

PROXIDERM (D-460,D 90 460,D 180,460, PS 460) is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Progressive Surgical Products, Inc.. The 510(k) number is K970439.

When did PROXIDERM (D-460,D 90 460,D 180,460, PS 460) receive FDA 510(k) clearance?

PROXIDERM (D-460,D 90 460,D 180,460, PS 460) received FDA 510(k) clearance on 1997-04-16, under 510(k) number K970439.

Who is the listed applicant for PROXIDERM (D-460,D 90 460,D 180,460, PS 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 (D-460,D 90 460,D 180,460, PS 460)?

The FDA product code for PROXIDERM (D-460,D 90 460,D 180,460, PS 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.

K982439PROXIDERM, MODELS TN 460, TN 90 460, BK 460K942425PROXIDERM (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.K982439PROXIDERM, MODELS TN 460, TN 90 460, BK 460Progressive 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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