510(k) K080412
- Device
- ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
- Applicant
- SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD.
- 510(k) number
- K080412
- Product code
- GAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-04
- Date received
- 2008-02-15
- 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
- BRANDON CHOI
- Address
- Flemington Ct. # 155 La Mirada CA US 90638 90638
FDA Registration Numbers#
- 3038718579
- 3003639970
- 2245304
- 3019924
- 3004215117
- 9680794
- 1061124
- 3012101664
- 3003595343
- 3027448274
- 3010041511
- 3004944585
- 3008868758
- 9710098
- 3010131137
- 9612501
- 3004111573
- 3015453963
- 2030624
- 3003267729
- 1531174
- 1221934
- 3001124136
- 2320762
- 9611459
- 1054241
- 2183744
- 3006638824
- 3015489699
- 1064514
- 3029901632
- 1064584
- 3017102971
- 3004117249
- 3014272734
- 3013187142
- 3014273254
- 3004903580
- 9681572
- 3013176080
- 1036836
- 3014615644
- 1319639
- 3011803381
- 3010419931
- 3010452421
- 3015330532
- 1018470
- 1043214
- 3010860245
- 3012421607
- 3003828812
- 3013644499
- 3018064853
- 1219930
- 1720929
- 3013548553
- 3007791599
- 2210968
- 3007009755
- 3003418325
- 3030733800
- 3004365956
- 2125050
- 2521877
- 1058584
- 3004192065
- 3006562124
- 3013557562
- 3011689956
- 3016904853
- 3007006186
- 1055236
- 2648623
- 3043225236
- 3004845555
- 3011137372
- 1825034
- 2183301
Source Documents#
Other 510(k) Records For Product Code GAM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K200140 | Silhouette Instalift | Silhouette Lift, Inc. | 2020-03-27 |
Legacy Summary#
summary
FDA Review#
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