Cleared Traditional

K861308 - ACCUPAC CUSTOM PACK KERLIX SQUARES

K861308 · Geneva Laboratories, Inc. · General & Plastic Surgery device
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May 1986
Decision
24d
Days
-
Risk

K861308 is an FDA 510(k) clearance for the ACCUPAC CUSTOM PACK KERLIX SQUARES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 24 days - a notably fast clearance 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: 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 Geneva Laboratories, Inc. devices

FDA 510(k) Submission Details - K861308

510(k) Number K861308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1986
Decision Date May 02, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
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 157
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K861308.
BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES
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STERILE LAPAROTOMY GAUZE SPONGE
K862126 · Anago, Inc. · Jun 1986
STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE
K852202 · Ormed Mfg., Inc. · Jun 1985
WET PACK
K843783 · E.M. Adams · Dec 1984
DRY TRAY
K843782 · E.M. Adams · Dec 1984