Cleared Traditional

ABSELE* ABSORBABLE BONE SEALANT (K802881) - FDA 510(k) Clearance

K802881 · Ethicon, Inc. · Ophthalmic device
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Dec 1980
Decision
32d
Days
-
Risk

K802881 is an FDA 510(k) clearance for the ABSELE* ABSORBABLE BONE SEALANT.

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 19, 1980 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Ophthalmic 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 Ethicon, Inc. devices

Submission Details

510(k) Number K802881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1980
Decision Date December 19, 1980
Days to Decision 32 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 110d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -