Cleared Special

K060878 - GELITA-SPON ABSORBABLE GELATIN SPONGE, USP

K060878 is an FDA 510(k) clearance for GELITA-SPON ABSORBABLE GELATIN SPONGE, manufactured by Curamedical, BV. The device is a Class 2 Ear, Nose, Throat device with product code KHJ cleared through the Special 510(k) pathway after a 13-day FDA review.

K060878 · Curamedical, BV · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
13d
Days
Class 2
Risk

K060878 is an FDA 510(k) clearance for the GELITA-SPON ABSORBABLE GELATIN SPONGE, USP. 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 April 13, 2006 after a review of 13 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Curamedical, BV devices

FDA 510(k) Submission Details - K060878

510(k) Number K060878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2006
Decision Date April 13, 2006
Days to Decision 13 days
Submission Type Special
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
77d faster than avg
Panel avg: 90d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

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 K060878.
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
K070093 · Ceremed , Inc. · Jan 2007
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE
K062280 · Ceremed , Inc. · Dec 2006
CLEARADEX GEL
K060561 · Cambridgemed · May 2006
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
K051487 · Doctor'S Research Group, Inc. · Dec 2005
GELITA-SPON
K051911 · Curamedical, BV · Dec 2005
SEPRAGEL ENT BIORESORBABLE PACKING/STENT
K043035 · Genzyme Corporation · Jul 2005