Cleared Traditional

K982648 - JOAN II

K982648 · Celanese Acetate Co. · General & Plastic Surgery device
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Sep 1998
Decision
63d
Days
-
Risk

K982648 is an FDA 510(k) clearance for the JOAN II. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Celanese Acetate Co. (Charlotte, US). The FDA issued a Cleared decision on September 30, 1998 after a review of 63 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 Celanese Acetate Co. devices

FDA 510(k) Submission Details - K982648

510(k) Number K982648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1998
Decision Date September 30, 1998
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 140
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