Cleared Traditional

K920978 - ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED

K920978 is an FDA 510(k) clearance for ULA (POLIGLECAPRONE 251) SYNTHETIC ABSO..., manufactured by Ethicon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAN cleared through the Traditional 510(k) pathway after a 715-day FDA review.

K920978 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
715d
Days
Class 2
Risk

K920978 is an FDA 510(k) clearance for the ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED. Classified as Suture, Absorbable, Synthetic (product code GAN), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on February 15, 1994 after a review of 715 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4830 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Ethicon, Inc. devices

FDA 510(k) Submission Details - K920978

510(k) Number K920978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date February 15, 1994
Days to Decision 715 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
600d slower than avg
Panel avg: 115d · This submission: 715d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAN Device Classification - Class 2, Special Controls

Product Code GAN Suture, Absorbable, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4830
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAN Suture, Absorbable, Synthetic

Devices cleared under the same product code (GAN) and FDA review panel - the closest regulatory comparables to K920978.
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
K003015 · Surgical Specialties Corp · Dec 2000
MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
K964072 · Ethicon, Inc. · Dec 1996
MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
K960653 · Ethicon, Inc. · Mar 1996
POLYSORB SYNTHETIC ABSORBABLE SUTURE
K895579 · United States Surgical, A Division of Tyco Healthc · Jul 1990