FDA 510(k)

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)

Numéro K : K260984 · 2026-08-18

Date de décision2026-08-18

Code produitHIH

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) is the device name listed in this FDA 510(k) record. The listed applicant is Axora Medical, Inc.. It received FDA 510(k) clearance on 2026-08-18 under 510(k) number K260984. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)?

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) is a medical device that received FDA 510(k) clearance on 2026-08-18. The listed applicant is Axora Medical, Inc.. The 510(k) number is K260984.

When did HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) receive FDA 510(k) clearance?

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) received FDA 510(k) clearance on 2026-08-18, under 510(k) number K260984.

Who is the listed applicant for HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)?

The FDA 510(k) record lists Axora Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)?

The FDA product code for HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) is HIH.

Essais cliniques associés

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Dispositifs connexes (Code : HIH)

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Source officielle

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