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FDA 510(k)

DERMTOME BLADE

K-Number: K962371 · 1996-08-29

ApplicantDsp Worldwide
Decision Date1996-08-29
Product CodeGFD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMTOME BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Dsp Worldwide. It received FDA 510(k) clearance on 1996-08-29 under 510(k) number K962371. The device is classified under product code GFD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMTOME BLADE?

DERMTOME BLADE is a medical device that received FDA 510(k) clearance on 1996-08-29. The listed applicant is Dsp Worldwide. The 510(k) number is K962371.

When did DERMTOME BLADE receive FDA 510(k) clearance?

DERMTOME BLADE received FDA 510(k) clearance on 1996-08-29, under 510(k) number K962371.

Who is the listed applicant for DERMTOME BLADE?

The FDA 510(k) record lists Dsp Worldwide as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMTOME BLADE?

The FDA product code for DERMTOME BLADE is GFD.

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 Dsp Worldwide 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.

K962544MICRO DIAMOND-POINT DISSECTION NEEDLESK962365XENON LIGHTSOURCE

Related Devices (Code: GFD)

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.

K965256DMS-1000C DERMOABRADERMattioli Engineering, SrlK945594DECA DERMATOME (MICROMOTOR SYSTEM)Depuy Intl., Ltd.K951085PADGETT AIR DERMATOME, MODEL APadgett Instruments, Inc.K940208AESCULAP ACCU-DERMATOMEAesculap, Inc.K862669ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTU. S. Diagnostics, Inc.K861285SKIN MESH DEVICEPrecision Modified Devices

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.

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