Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

The Disposable Biopsy Forceps FB Series (FB-211D, FB-221D, FB-231D, FB-241D) are sterile, single-use biopsy forceps designed to collect tissue from the upper airways (nasal and nasopharyngeal regions) when used with compatible rhino-laryngoscopes. Each model features a different distal cup shape: alligator jaw-step, alligator jaw-step with needle, oval type, or oval type with needle.

The subject device is disposable and sterilized by gamma radiation, compared to the predicate (FB-56D-1) which is reusable and autoclaved. The subject has a maximum insertion portion diameter of 1.9 mm versus 1.15 mm for the predicate. Both share identical 1150 mm working length. The subject is compatible with modern endoscopes (BF, ENF) with multiple channel diameters (2.0–3.2 mm), whereas the predicate was designed for older models (CHF, BF, URF, HYF) with a 1.2 mm channel.

ISO 11607-1:2019, ASTM F1980-21 (shelf life and packaging validation); ISO 10993-1:2018 and related cytotoxicity, sensitization, irritation, and systemic toxicity standards (ISO 10993-5, 10, 23, 11); ISO 11137 (sterilization validation); mechanical and human factors testing per FDA guidance.

Both devices serve the same intended use of collecting tissue from the upper airways with a rhino-laryngoscope. Non-clinical bench testing, biocompatibility studies, sterilization and packaging validation demonstrate the subject device performs as safely and effectively as the predicate despite differences in reusability, sterilization method, and compatible endoscope specifications. These differences do not affect the fundamental safety and effectiveness of tissue collection.