# K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Mar 28, 1996 after 42 days
- Product code: GAN (Suture, Absorbable, Synthetic)
- Device class: 2
- Regulation: 21 CFR 878.4830
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
193 later devices descend from it; 8 cite it directly.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MONOCRYL (poliglecaprone 25) suture, dyed: named in the summary without a submission number

## Most influential descendants
- K014183: Afb (Absorbable Foam Buttress) (2002), 145 descendants of its own
- K030782: Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 143 descendants of its own
- K032865: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 102 descendants of its own
- K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2004), 77 descendants of its own
- K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration (2004), 69 descendants of its own

## Recalls of this device
- May 10, 2024 · Class II · Z-2148-2024: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Feb 2, 2009 · Not classified · Z-1311-2009: Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

## Indications for use
MONOCRYL sutures, dyed are indicated for 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/K960653
Methodology: https://510kreport.com/methodology