Cleared Traditional

K051911 - GELITA-SPON

K051911 is an FDA 510(k) clearance for GELITA-SPON, manufactured by Curamedical, BV. The device is a Class 2 Ear, Nose, Throat device with product code KHJ cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K051911 · Curamedical, BV · Ear, Nose, Throat device
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Dec 2005
Decision
145d
Days
Class 2
Risk

K051911 is an FDA 510(k) clearance for the GELITA-SPON. Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Curamedical, BV (Claremont, US). The FDA issued a Cleared decision on December 6, 2005 after a review of 145 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 Curamedical, BV devices

FDA 510(k) Submission Details - K051911

510(k) Number K051911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2005
Decision Date December 06, 2005
Days to Decision 145 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
55d slower than avg
Panel avg: 90d · This submission: 145d
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 27
Devices cleared under the same product code (KHJ) and FDA review panel - the closest regulatory comparables to K051911.
CLEARADEX GEL
K060561 · Cambridgemed · May 2006
GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
K060878 · Curamedical, BV · Apr 2006
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
K051487 · Doctor'S Research Group, Inc. · Dec 2005
SEPRAGEL ENT BIORESORBABLE PACKING/STENT
K043035 · Genzyme Corporation · Jul 2005
MEROGEL OTOLOGIC PACK
K001148 · Xomed, Inc. · Jun 2000
TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
K991324 · Heinz Kurz · May 1999