FDA 510(k)

Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)

K-Nummer: K252211 · 2025-08-11

Entscheidungsdatum2025-08-11

ProduktcodeGEI

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) is the device name listed in this FDA 510(k) record. The listed applicant is Cnc Technologies. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K252211. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)?

Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Cnc Technologies. The 510(k) number is K252211.

When did Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) receive FDA 510(k) clearance?

Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) received FDA 510(k) clearance on 2025-08-11, under 510(k) number K252211.

Who is the listed applicant for Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)?

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

What is the FDA product code for Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)?

The FDA product code for Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) is GEI.

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Offizielle Quelle

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