510(k) · Cleared
ClearedMonoglyde, Absorbable (Poliglecaprone 25) Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sutures India Pvt., Ltd. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jun 9, 2008 as substantially equivalent to K930772 (ETHICON, Inc., 1994) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jun 9, 2008
- Review
- 62 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930772 (1994). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK930772 Ethicon* Monocryl (Poliglecaprone 25) SutureETHICON, Inc. · 1994
- This deviceK081002 Monoglyde, Absorbable (Poliglecaprone 25) SutureSutures India Pvt., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK130083 Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL)…Demetech Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK232372 Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930772 | Ethicon* Monocryl (Poliglecaprone 25) Suture | ETHICON, Inc. | 1994 | — |
| 0 (this device) | K081002 | Monoglyde, Absorbable (Poliglecaprone 25) Suture | Sutures India Pvt., Ltd. | 2008 | — |
| +1 | K130083 | Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture | Demetech Corp. | 2013 | — |
| +2 | K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2024 | 1 | 0 |
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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K930772 | Ethicon* Monocryl (Poliglecaprone 25) SutureSummary page 1…) · Classification Name : Absorbable (Poliglecaprone 25) suture E. PREDICATE DEVICES A. Monocryl, Absorbable (Poliglecaprone 25) sutures, 510(k) Number K930772, Ethicon Incorporation, Somerville, NJ 088760151 B. Unicaprone Absorbable (Poliglecaprone 25) Suture, 510(k) Number K0… | 1994 |
| * | K072646 | UnicaproneSummary page 1…caprone 25) sutures, 510(k) Number K930772, Ethicon Incorporation, Somerville, NJ 088760151 B. Unicaprone Absorbable (Poliglecaprone 25) Suture, 510(k) Number K072646, United Medical Industries Co.Ltd (UNIMED), Riyadh, SA 11553 SUTURES INDIA PVT.LTD… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130083 | Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture | 2013 | 1 |
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?
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
MONOGLYDE IS A SYNTHETIC ABSORBABLE (POLIGLECAPRONE 25) SURGICAL SUTURE, STERILE FLEXIBLE STRAND, PREPARED AND SYNTHESIZED FROM THE MONOMERS, POLYGLYCOLIC ACiD 75% AND CAPROLACTONE 25% AND IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION, BUT NOT FOR USE IN OPHTHALMIC SURGERY, CARDIO-VASCULAR AND NEUROLOGICAL TISSUES
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081002: Monoglyde, Absorbable (Poliglecaprone 25) Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081002
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