510(k) K221527
- Device
- StitchKit
- Applicant
- Origami Surgical Inc .
- 510(k) number
- K221527
- Product code
- GAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-14
- Date received
- 2022-05-26
- 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
- John Gillespie
- Address
- 42 Main St. Madison NJ US 07940 07940
FDA Registration Numbers#
- 1614993
- 3024021261
- 1423537
- 3006425876
- 3027448274
- 2528981
- 3006981798
- 3015330532
- 1064514
- 1423662
- 3006680097
- 3003639970
- 3003300673
- 2648623
- 3015489699
- 3004431266
- 2020601
- 3017196117
- 9616088
- 3009968482
- 3018094310
- 3011085362
- 3020983460
- 1319639
- 1054241
- 3008868758
- 3006562124
- 2245304
- 9611459
- 3004117249
- 3018052045
- 3004903580
- 3013644499
- 3004192065
- 1320468
- 3007791573
- 1018470
- 9710098
- 1000274611
- 2125050
- 3000268902
- 1219930
- 3013188547
- 3014479313
- 3018064853
- 3014592276
- 3017102971
- 3013403214
- 3038718579
- 1055236
- 1221601
- 3010419931
- 3004111573
- 3003267729
- 3010864832
- 1825034
- 3002294946
- 3010692967
- 3015453963
- 3009380063
- 1036836
- 1221934
- 2521877
- 3003828812
- 1061124
- 3011276344
- 3014273254
- 3004365956
- 3004060107
- 3013187142
- 3015207155
- 3029901632
- 3003418325
- 3030733800
- 3007205024
- 3016904853
- 1043214
- 2320762
- 3012101664
Source Documents#
Other 510(k) Records For Product Code GAM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K200140 | Silhouette Instalift | Silhouette Lift, Inc. | 2020-03-27 |
| K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2019-12-18 |
| K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | 2019-06-27 |