510(k) K930943
- Device
- LUKENS NYLON SURGICAL SUTURE
- Applicant
- LUKENS MEDICAL CORP.
- 510(k) number
- K930943
- Product code
- GAR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-12-17
- Date received
- 1993-02-23
- Regulation
- 878.5020
- Classification name
- Suture, Nonabsorbable, Synthetic, Polyamide
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRENDA KELLY
- Address
- The Lahr Consulting Group,Inc. One Lethbridge Plz. Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3013849323
- 3029901632
- 3004845555
- 2245304
- 3018094310
- 2320762
- 1054241
- 3044819802
- 1221051
- 3006425876
- 3006638824
- 3003915875
- 3012342459
- 3017102971
- 2183301
- 3010864832
- 3007791573
- 9616088
- 9611459
- 3038718579
- 3014117096
- 3007074233
- 1054811
- 1037089
- 1017294
- 1721676
- 3029754081
- 3045855232
- 1055236
- 2032098
- 3045857302
- 3020983460
- 3004111573
- 3015330532
- 3017196117
- 3004060107
- 3009513193
- 1221601
- 2648623
- 3014615644
- 9710098
- 3013557562
- 3014461810
- 1043214
- 1058584
- 1062668
- 2246552
- 3004944585
- 3010041511
- 1219930
- 9612501
- 3014276972
- 3006981798
- 3010131137
- 3022766613
- 3030446844
- 3012101664
- 3016426842
- 3011689956
- 2521877
- 3012502601
- 9680794
- 2030624
- 2085887
- 3013298431
- 9611484
- 3006562124
- 3004365956
- 3014273254
- 3011137372
- 1061124
- 3005953126
- 3007791599
- 1064514
- 3003267729
- 3012421607
- 3014592276
- 1000274611
- 3013403214
- 2244478
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K212888 | Golnit Nylon Monofilament Suture | Antarma, LLC Dba Golnit Sutures | 2022-03-31 |
| 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 |
Legacy Summary#
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FDA Review#
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