510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962371Substantially Equivalent

Dermtome Blade

Dsp Worldwide, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962371 is the FDA 510(k) clearance record for DERMTOME BLADE, a class I device, cleared for Dsp Worldwide on under FDA product code GFD (Dermatome). FDA records list 3 510(k) clearances for Dsp Worldwide, from to . As of , FDA records show no recalls naming K962371.

Clearance record

Decision date
Received
(71 days to decision)
Product code
GFD Dermatome
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Dsp Worldwide 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code GFD

Trailing 12 months

FDA records hold no clearances under product code GFD in the trailing twelve months.

FDA records show no clearances under product code GFD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260