Cleared Traditional

ABSORABLE POLYGLACTIN 910-ANASTOMOTIC (K833081) - FDA 510(k) Clearance

K833081 · Ethicon, Inc. · General & Plastic Surgery device
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Jan 1984
Decision
140d
Days
-
Risk

K833081 is an FDA 510(k) clearance for the ABSORABLE POLYGLACTIN 910-ANASTOMOTIC.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 140 days - within the typical 510(k) review window.

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 Ethicon, Inc. devices

Submission Details

510(k) Number K833081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1983
Decision Date January 27, 1984
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -