Cleared Traditional

K970910 - XOMED SILICONE BLOCK/STRIP

K970910 is the FDA 510(k) clearance for XOMED SILICONE BLOCK/STRIP by Xomed, Inc.. It is a Class 2 Ear, Nose, Throat device (product code KHJ) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K970910 · Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
51d
Days
Class 2
Risk

K970910 is an FDA 510(k) clearance for the XOMED SILICONE BLOCK/STRIP. Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 2, 1997 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xomed, Inc. devices

Submission Details

510(k) Number K970910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1997
Decision Date May 02, 1997
Days to Decision 51 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
38d faster than avg
Panel avg: 89d · This submission: 51d
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.

Regulatory Peers - KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)

All 9
Devices cleared under the same product code (KHJ) and FDA review panel - the closest regulatory comparables to K970910.
XOMED SILICONE PRE-FORM BLOCKS
K982294 · Xomed, Inc. · Sep 1998
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
K972700 · Exmoor Plastics , Ltd. · Jul 1998
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
K974311 · Gyrus Ent LLC · Mar 1998
KARTUSH TM PATCHER
K964484 · Xomed, Inc. · Jan 1997
EXMOOR SILICONE RUBBER SHEET
K911503 · Exmoor Plastics , Ltd. · Nov 1991