510(k) K151200
- Device
- STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- Applicant
- ETHICON, INC.
- 510(k) number
- K151200
- Product code
- GAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-13
- Date received
- 2015-05-05
- Regulation
- 878.4493
- Classification name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONNA MARSHALL
- Address
- Rte. 22 W. P.O. Box 151 Somerville NJ US 08876 08876
FDA Registration Numbers#
- 2125050
- 3007205024
- 3010041511
- 3005972890
- 3010419931
- 1721676
- 3013188547
- 1036836
- 1221934
- 1423662
- 1319639
- 3006680097
- 3003267729
- 3007791573
- 3011683674
- 3006425876
- 9617547
- 3013403214
- 2246552
- 3020983460
- 3014276972
- 3045857302
- 3004192065
- 3010692967
- 3003595343
- 1423537
- 1064584
- 3000268902
- 3011276344
- 9612501
- 3044819802
- 3029901632
- 3014479313
- 3004060107
- 9680794
- 1531174
- 3003418325
- 3004903580
- 3016904853
- 3018094310
- 1221601
- 2650143
- 3003639970
- 3007009755
- 3030733800
- 1058584
- 2245304
- 3012502601
- 3011085362
- 3013187142
- 3013176080
- 3014579161
- 1061124
- 2210968
- 1614993
- 1043214
- 3015489699
- 9616088
- 3004111573
- 3014272734
- 3012421607
- 3004431266
- 3012101664
- 2648623
- 3014461810
- 1037089
- 3035366890
- 3043225236
- 3004215117
- 3013298431
- 3043226252
- 1018470
- 9710098
- 1319660
- 3045855232
- 3013548553
- 3017196117
- 3015330532
- 2521877
- 3019924
Source Documents#
Other 510(k) Records For Product Code GAM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253394 | Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture | ETHICON, Inc. | 2026-06-25 |
| K253530 | Trexon™ Monofilament Synthetic Absorbable Suture | Medtronic | 2026-05-28 |
| K253852 | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | 2026-02-06 |
| K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | ETHICON, Inc. | 2025-12-22 |
| K253620 | TroClose 1200 | Gordian Surgical, Ltd. | 2025-12-16 |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) | Internacional Farmacéutica S.A DE C.V | 2025-10-03 |
| K233265 | Monotime and Optime R | Peters Surgical | 2024-10-11 |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | 2024-07-12 |
| K221527 | StitchKit | Origami Surgical Inc . | 2023-02-14 |
| K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | ETHICON, Inc. | 2022-11-15 |
| K212810 | MONOFIX PGCL, knotless wound closure device | Samyang Holdings Corp., Ltd. | 2022-08-05 |
| K211792 | StitchKit | Origami Surgical Inc . | 2021-07-16 |
| K202950 | StitchKit COMBO | Origami Surgical | 2021-02-23 |
| K201996 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | 2020-12-21 |
| K200392 | REXSIN | Sm Eng Co., Ltd. | 2020-07-07 |
Legacy Summary#
summary
FDA Review#
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