510(k) K021767
- Device
- ASSUFIL
- Applicant
- ASSUT EUROPE S.P.A.
- 510(k) number
- K021767
- Product code
- GAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-19
- Date received
- 2002-05-29
- 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
- LUCIO IMPROTA
- Address
- 10147 Umberland Pl. Boca Raton FL US 33428 33428
FDA Registration Numbers#
- 3010131137
- 3012421607
- 1221934
- 3014279513
- 3004845555
- 9616088
- 1221601
- 1061124
- 3004903580
- 2183301
- 3015489699
- 3027448274
- 3013188547
- 2528981
- 3008912461
- 3016904853
- 3020983460
- 3013644499
- 1721676
- 1720929
- 3013403214
- 3013187142
- 1064584
- 3006425876
- 3003639970
- 3011137372
- 3010419931
- 3006562124
- 3010452421
- 3006680097
- 3001124136
- 3038718579
- 1825034
- 3014461810
- 3008114965
- 3014579161
- 1066741
- 1037089
- 1036836
- 3003595343
- 3013298431
- 1320468
- 3029901632
- 9681572
- 3035366890
- 3004192065
- 3013548553
- 3003267729
- 3030733800
- 2245304
- 3017196117
- 3014479313
- 3011803381
- 3015542154
- 3000268902
- 3002692886
- 1423662
- 1000274611
- 9617547
- 3010692967
- 3013557562
- 3010864832
- 3004215117
- 3010041511
- 3004431266
- 3014276972
- 3011689956
- 9710098
- 3007205024
- 2020601
- 1055236
- 3009380063
- 3010860245
- 2125050
- 3003300673
- 3012101664
- 3015330532
- 3018052045
- 3004944585
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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