Cleared Traditional

K972700 - EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE ...

K972700 is an FDA 510(k) clearance for EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE ..., manufactured by Exmoor Plastics , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code KHJ cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K972700 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
393d
Days
Class 2
Risk

K972700 is an FDA 510(k) clearance for the EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS P.... Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on July 16, 1998 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Exmoor Plastics , Ltd. devices

FDA 510(k) Submission Details - K972700

510(k) Number K972700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1997
Decision Date July 16, 1998
Days to Decision 393 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
304d slower than avg
Panel avg: 89d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHJ Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (KHJ) and FDA review panel - the closest regulatory comparables to K972700.
MEROGEL OTOLOGIC PACK
K001148 · Xomed, Inc. · Jun 2000
EPIFILM OTOLOGIC LAMINA
K982870 · Xomed, Inc. · Nov 1998
XOMED SILICONE PRE-FORM BLOCKS
K982294 · Xomed, Inc. · Sep 1998
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
K974311 · Gyrus Ent LLC · Mar 1998
XOMED SILICONE BLOCK/STRIP
K970910 · Xomed, Inc. · May 1997
KARTUSH TM PATCHER
K964484 · Xomed, Inc. · Jan 1997