Cleared Traditional

K983016 - GAUZE, SPONGES, CAT # 11-003

K983016 · Vitalcare Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
168d
Days
-
Risk

K983016 is an FDA 510(k) clearance for the GAUZE, SPONGES, CAT # 11-003. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Vitalcare Group, Inc. (Miami, US). The FDA issued a Cleared decision on February 12, 1999 after a review of 168 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitalcare Group, Inc. devices

FDA 510(k) Submission Details - K983016

510(k) Number K983016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1998
Decision Date February 12, 1999
Days to Decision 168 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 115d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K983016.
VITOP DRESSING
K990974 · Wonder & Bioenergy Hi-Tech America, Inc. · Jun 1999
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
K990584 · Broadline Medical Industries · Apr 1999
CROSSTEX NON-WOVEN SPONGES
K984187 · Crosstex Intl. · Feb 1999
DYNAREX TRACHEOSTOMY SPONGE
K983348 · Dynarex Corp. · Dec 1998
STARRYSHINE GAUZE SPONGE
K983450 · T.C. Dental Products, Inc. · Nov 1998
JOAN II
K982648 · Celanese Acetate Co. · Sep 1998