Cleared Traditional

K232646 - Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6) (FDA 510(k) Clearance)

Also includes:
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232646 · Cook Biotech Incorporated · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
268d
Days
Class 2
Risk

K232646 is an FDA 510(k) clearance for the Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6). Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Cook Biotech Incorporated (West Lafayette, US). The FDA issued a Cleared decision on May 24, 2024 after a review of 268 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Biotech Incorporated devices

Submission Details

510(k) Number K232646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2023
Decision Date May 24, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 89d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.