Cleared Traditional

K962693 - MONTGOMERY RADIOPAQUE LARYNGEAL KEEL

K962693 is an FDA 510(k) clearance for MONTGOMERY RADIOPAQUE LARYNGEAL KEEL, manufactured by Boston Medical Products, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code FWN cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K962693 · Boston Medical Products, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
29d
Days
Class 2
Risk

K962693 is an FDA 510(k) clearance for the MONTGOMERY RADIOPAQUE LARYNGEAL KEEL. Classified as Prosthesis, Larynx (stents And Keels) (product code FWN), Class II - Special Controls.

Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on August 9, 1996 after a review of 29 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 Boston Medical Products, Inc. devices

FDA 510(k) Submission Details - K962693

510(k) Number K962693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1996
Decision Date August 09, 1996
Days to Decision 29 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
60d faster than avg
Panel avg: 89d · This submission: 29d
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)

All 7
Devices cleared under the same product code (FWN) and FDA review panel - the closest regulatory comparables to K962693.
RUTTER SUPRA STOMAL STENTS
K091135 · Boston Medical Products, Inc. · Sep 2009
LORENZ STENT
K896667 · Walter Lorenz Surgical, Inc. · Feb 1990
SILICONE LARYNGEAL STENT
K884810 · Hood Laboratories · May 1989
'EXMOOR' DAS GUPTA LARYNGEAL KEEL
K864936 · Exmoor Plastics , Ltd. · Apr 1987
LARYNGEAL
K853726 · Hood Laboratories · Mar 1986
MONTG. LARYNGEAL KEEL
K842800 · Boston Medical Products, Inc. · Aug 1984