510(k) · Cleared
ClearedCutalon Nylon Polyamide Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Surgical Product (Genzyme Biosurgery) · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Jul 7, 1998 as substantially equivalent to K930738 (Deknatel, Inc., 1994) after an 88-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jul 7, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930738 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- This deviceK981322 Cutalon Nylon Polyamide Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc | Deknatel, Inc. | 1994 | 9 |
| 0 (this device) | K981322 | Cutalon Nylon Polyamide Surgical Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GAR device
- #1 K261484 Tissue Approximation Systemscore 11.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc Our OCR of the scanned summary read “K930738” beside “510(k)”; FDA’s K930738 is the only number that fits it and was decided on the date printed beside it. Summary page 5…Suture has been on the market since December 1976. In Appendix C, please see a copy of NDA 85-060 FDA letter from December 1976 and also see a copy of the FDA’s 510(k) #K930738 letter dated July 26, 1994 which confirms that Genzyme has followed the instructions for “Suture Labeling Guidance” dated October… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 8 other devices also cite its predicate K930738.
How does its category compare?
All GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAR
Too few GAR 510(k)s in any year since 2007 to give a median.
Recalls per year · GAR
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAR
823in 2025
MAUDE reports naming product code GAR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 18 |
| 2008 | 1 | — | 1 | 14 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 103 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 1 | — | 0 | 124 |
| 2017 | 1 | — | 0 | 180 |
| 2018 | 0 | — | 0 | 541 |
| 2019 | 0 | — | 0 | 518 |
| 2020 | 1 | — | 0 | 384 |
| 2021 | 1 | — | 0 | 532 |
| 2022 | 1 | — | 0 | 549 |
| 2023 | 1 | — | 1 | 607 |
| 2024 | 0 | — | 0 | 668 |
| 2025 | 0 | — | 0 | 823 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
“Cutalon” Nonabsorbable Polyamide Surgical Sutures are provided sterile and are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981322: Cutalon Nylon Polyamide Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981322
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026