510(k) K212888
- Device
- Golnit Nylon Monofilament Suture
- Applicant
- Antarma LLC Dba Golnit Sutures
- 510(k) number
- K212888
- Product code
- GAR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-31
- Date received
- 2021-09-10
- Regulation
- 878.5020
- Classification name
- Suture, Nonabsorbable, Synthetic, Polyamide
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Armine Badalyan
- Address
- 276 5th Ave., Suite 704 New York NY US 10001 10001
FDA Registration Numbers#
- 3004845555
- 3014276972
- 1221601
- 1037089
- 3011689956
- 3013298431
- 9611484
- 3013849323
- 1062668
- 1017294
- 9614747
- 2648623
- 3003915875
- 9616088
- 3007791573
- 3014273254
- 1721676
- 2183301
- 2246552
- 3013187142
- 1054811
- 3045855232
- 3012342459
- 1064017
- 3010452421
- 3007791599
- 1064514
- 3013403214
- 3045857302
- 3029835193
- 1043214
- 3017196117
- 1018470
- 3010162973
- 1066741
- 3006562124
- 1221051
- 1930126
- 2648650
- 3012101664
- 1423537
- 3011560638
- 3022766613
- 2032098
- 3018052045
- 9710098
- 3020983460
- 3008912461
- 3004192065
- 3032543753
- 3014461810
- 9611459
- 9612501
- 1054241
- 3012026312
- 3044819802
- 3013002341
- 3004060107
- 3005953126
- 3014615644
- 2521877
- 3004365956
- 3004117249
- 1058584
- 2030624
- 2085887
- 3030733800
- 3002692886
- 3014117096
- 9680794
- 3017636737
- 3006638824
- 1226146
- 3014579161
- 3007074233
- 1111225
- 3010041511
- 1062741
- 3013557562
- 3029754081
Source Documents#
Other 510(k) Records For Product Code GAR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261484 | Tissue Approximation System | Tas Medical, Inc. | 2026-06-03 |
| K220980 | Tissue Approximation System (TAS) | Tas Medical, Inc. | 2023-07-05 |
| K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | 2021-12-22 |
| K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | 2020-05-29 |
| K161633 | REXLON, REXSIL | Sm Eng Co., Ltd. | 2017-03-02 |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016-02-17 |
| K152795 | RiverLon (Nylon) Suture | Riverpoint Medical | 2015-10-28 |
| K123034 | VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED | Unilene Sac | 2013-05-28 |
| K081366 | KUMAR T-ANCHORS HERNIA SET | Nashville Surgical Instruments | 2008-07-15 |
| K060471 | FSSB NYLON SURGICAL SUTURES | Fssb Chirurgische Nadeln GmbH | 2006-07-26 |
| K053637 | MANI NEEDLE & SUTURE PACK (NYLON) | Mani, Inc. | 2006-05-19 |
| K060528 | AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE | Aesculap, Inc. | 2006-03-28 |
| K052900 | QUILL NONABSORBABLE NYLON BARBED SUTURE | Quill Medical, Inc. | 2005-11-28 |
| K052482 | ARTELON SURGICAL SUTURE | Artimplant AB | 2005-10-17 |
| K041510 | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | Sutures India Private Limited | 2005-06-02 |
Legacy Summary#
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FDA Review#
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