Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GAM — Predicate Candidate Screening
149 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
268 days90th percentile
149clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253394 | Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture | ETHICON, Inc. | 2026-06-25 | 268 | 0 |
| K253530 | Trexon™ Monofilament Synthetic Absorbable Suture | Medtronic | 2026-05-28 | 196 | 0 |
| K253852 | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilame | ETHICON, Inc. | 2026-02-06 | 66 | 0 |
| K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; | ETHICON, Inc. | 2025-12-22 | 116 | 0 |
| K253620 | TroClose 1200 | Gordian Surgical, Ltd. | 2025-12-16 | 28 | 0 |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calyps | Internacional Farmacéutica S.A DE C.V | 2025-10-03 | 29 | 0 |
| K233265 | Monotime and Optime R | Peters Surgical | 2024-10-11 | 378 | 0 |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | 2024-07-12 | 339 | 0 |
| K221527 | StitchKit | Origami Surgical Inc . | 2023-02-14 | 264 | 0 |
| K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Dev | ETHICON, Inc. | 2022-11-15 | 152 | 0 |
| K212810 | MONOFIX PGCL, knotless wound closure device | Samyang Holdings Corp., Ltd. | 2022-08-05 | 336 | 0 |
| K211792 | StitchKit | Origami Surgical Inc . | 2021-07-16 | 36 | 0 |
| K202950 | StitchKit COMBO | Origami Surgical | 2021-02-23 | 146 | 0 |
| K201996 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | 2020-12-21 | 154 | 1 |
| K200392 | REXSIN | Sm Eng Co., Ltd. | 2020-07-07 | 140 | 0 |
| K200140 | Silhouette Instalift | Silhouette Lift, Inc. | 2020-03-27 | 66 | 0 |
| K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissu | ETHICON, Inc. | 2019-12-18 | 90 | 1 |
| K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical | ETHICON, Inc. | 2019-06-27 | 220 | 3 |
| K183001 | WEGO-PGLA RAPID | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 | 90 | 0 |
| K183004 | WEGO-PGA RAPID | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 | 90 | 0 |
| K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable | ETHICON, Inc. | 2018-09-28 | 98 | 1 |
| K181320 | Caprolon | Resorba Medical GmbH | 2018-09-18 | 123 | 0 |
| K180625 | Rondek PGA Suture (Beige or Violet) | Rk Manufacturing Corporation | 2018-05-10 | 62 | 0 |
| K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | Origami Surgical, LLC | 2018-05-04 | 134 | 0 |
| K173779 | REXMONO, PDREX | Sm Eng Co., Ltd. | 2018-03-12 | 90 | 0 |
| K173043 | Holycon Synthetic Absorbable Sutures | Nantong Holycon Medical Devices Co., Ltd. | 2017-12-14 | 77 | 0 |
| K171001 | Monosyn Quick Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 2017-10-23 | 202 | 0 |
| K170166 | CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglact | Cpt Sutures Co., Ltd. | 2017-09-29 | 253 | 0 |
| K172659 | MEGASORB - Natural absorbable Polyglycolic Acid Surgical Sut | M/s. Meril Endo Surgery Private Limited. | 2017-09-28 | 23 | 0 |
| K163676 | Silhouette InstaLift | Silhouette Lift, Inc. | 2017-06-16 | 171 | 0 |
| K171494 | TroClose1200, TroClose1200 Cannula | Gordian Surgical, Ltd. | 2017-06-15 | 24 | 0 |
| K170661 | Novosyn Quick Absorbable Suture | Aesculap, Inc. | 2017-06-08 | 97 | 0 |
| K161629 | CRYLREX | Sm Eng Co., Ltd. | 2017-02-10 | 242 | 0 |
| K160564 | TroClose1200 | Gordian Surgical, Ltd. | 2016-11-17 | 262 | 0 |
| K161726 | E-Pack Procedure Kit | ETHICON, Inc. | 2016-07-12 | 20 | 0 |
| K153611 | Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable | Ethicon, LLC | 2016-06-03 | 169 | 0 |
| K143584 | PGA RESORBA, PGA RESOQUICK, GLYCOLON | Resorba Medical GmbH | 2015-11-02 | 319 | 0 |
| K150717 | Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron | M/s. Meril Endo Surgery Private Limited. | 2015-10-14 | 209 | 0 |
| K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, ST | ETHICON, Inc. | 2015-08-13 | 100 | 1 |
| K142061 | SILHOUETTE INSTALIFT | Silhouette Lift, Inc. | 2015-04-24 | 268 | 0 |
| K142822 | PLIASURE Polyglycolide Synthetic Absorbable Suture | ETHICON, Inc. | 2015-03-26 | 177 | 0 |
| K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | Foosin Medical Supplies Inc., Ltd. | 2014-11-14 | 46 | 0 |
| K140039 | POLYCRYL | Aurolab | 2014-09-15 | 251 | 0 |
| K141778 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP | Surgical Specialties Corporation | 2014-07-30 | 28 | 0 |
| K141625 | POLYSYN SURGICAL SUTURE | Surgical Specialties Corp | 2014-07-18 | 31 | 0 |
| K141558 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE | Surgical Specialties Corp | 2014-07-11 | 29 | 0 |
| K123940 | DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE | Demetech Corp. | 2014-05-30 | 526 | 0 |
| K140227 | MONODERM SURGICAL SUTURE | Surgical Specialties Corp | 2014-02-28 | 29 | 0 |
| K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC | ETHICON, Inc. | 2014-02-28 | 196 | 0 |
| K130737 | SYNTHETIC ABSORBABLE SUTURE | Foosin Medical Supplies Inc., Ltd. | 2014-01-14 | 302 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda