# K201996: Monocryl Plus Antibacterial Suture

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Dec 21, 2020 after 154 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960653 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050845: Monocryl Plus Antibacterial Suture, ETHICON, Inc. (2005) Summary page 4.

## Most influential descendants
- K253852: MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture (2026), 0 descendants of its own

## Recalls of this device
- May 10, 2024 · Class II · Z-2149-2024: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

## Indications for use
MONOCRYL™ Plus Antibacterial Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Source page: https://510kreport.com/device/K201996
Methodology: https://510kreport.com/methodology