Cleared Traditional

K864936 - 'EXMOOR' DAS GUPTA LARYNGEAL KEEL

K864936 is an FDA 510(k) clearance for 'EXMOOR' DAS GUPTA LARYNGEAL KEEL, manufactured by Exmoor Plastics , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code FWN cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K864936 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
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Apr 1987
Decision
132d
Days
Class 2
Risk

K864936 is an FDA 510(k) clearance for the 'EXMOOR' DAS GUPTA LARYNGEAL KEEL. Classified as Prosthesis, Larynx (stents And Keels) (product code FWN), Class II - Special Controls.

Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on April 27, 1987 after a review of 132 days - within the typical 510(k) review window.

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 Exmoor Plastics , Ltd. devices

FDA 510(k) Submission Details - K864936

510(k) Number K864936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1986
Decision Date April 27, 1987
Days to Decision 132 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 89d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FWN Device Classification - Class 2, Special Controls

Product Code FWN Prosthesis, Larynx (stents And Keels)
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 - FWN Prosthesis, Larynx (stents And Keels)

Devices cleared under the same product code (FWN) and FDA review panel - the closest regulatory comparables to K864936.
RUTTER SUPRA STOMAL STENTS
K091135 · Boston Medical Products, Inc. · Sep 2009
MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
K962693 · Boston Medical Products, Inc. · Aug 1996
LORENZ STENT
K896667 · Walter Lorenz Surgical, Inc. · Feb 1990
MONTG. LARYNGEAL KEEL
K842800 · Boston Medical Products, Inc. · Aug 1984
MONTGOMERY LARYNGEAL STENT
K842287 · Boston Medical Products, Inc. · Jun 1984