510(k) Report

FDA product code · General and plastic surgery

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

PTXClass II21 CFR 878.4495510(k) exempt0 decisions0 recalls

FDA lists PTX as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

This product code is the class II exempt counterpart of GAQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State”…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of PTX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PTX

FDA has decided no PTX device since 2007.

Median 510(k) review, days · PTX

Too few PTX 510(k)s in any year since 2007 to give a median.

Recalls per year · PTX

No recall names PTX since 2007.

Adverse event reports per year · PTX

3in 2024

2020: 22021: 12023: 22024: 3
2007high 3 (2024) · low 0 (2007)2025

MAUDE reports naming product code PTX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—02
20210—01
20220—00
20230—02
20240—03
20250—00
20260—0—
FIG. 1 — PTX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PTX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 878.4495.

GAQ Suture, Nonabsorbable, Steel, Monofilament And…NJU Suture, Nonabsorbable, NitinolGAO Suture, Nonabsorbable