# K072229: Monoswift

- Pathway: 510(k) (Abbreviated)
- Applicant: Cp Medical
- Decided: Oct 5, 2007 after 56 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: 1 generation back to K960653 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002190: Polyglycolic Acid (Pga), Absorbable Surgical Suture (Usp), Cp Medical (2000) Summary page 1.
- K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified), ETHICON, Inc. (1996). Our reading of the summary gave K960053, FDA’s number for Selfcare Blood Glucose Test Strips for the Exactech System (Selfcare, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ethicon Monocryl (dyed)”.
- K964072: Monocryl (Poliglecaprone 25) Suture, Undyed, ETHICON, Inc. (1996) Summary page 1.

## Recalls of this device
- Feb 2, 2017 · Class II · Z-1872-2017: The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.

## Indications for use
Monoswift TM is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

Source page: https://510kreport.com/device/K072229
Methodology: https://510kreport.com/methodology