FDA 510(k) clearance · back to tracker

WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)

Wontech Co., Ltd. cleared K241643 on 2025-02-14, decision: substantially equivalent

K-number

K241643

Sponsor

Wontech Co., Ltd.

Device

WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-02-14

Product code

GEX

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4810

Official FDA record

Open K241643on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.