Product code GAT
- Device name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5000
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N16374S036 | PRONOVA ABSORABLE SUTURE, USP | ETHICON, Inc. | 1999-06-24 |
| P810028S011 | DEKLENE(TM) | Deknatel, Inc. | 1989-06-16 |
| P810028S010 | DEKLENE(TM) | Deknatel, Inc. | 1989-02-02 |
| P810028S008 | DEKLENE(TM) | Deknatel, Inc. | 1989-01-31 |
| N16374S034 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1988-10-07 |
| P810028S006 | DEKLENE(TM) | Deknatel, Inc. | 1988-07-14 |
| N17825S017 | SURGILENE | Davis & Geck, Inc. | 1988-06-06 |
| P810028S009 | DEKLENE(TM) | Deknatel, Inc. | 1988-04-28 |
| N17825S016 | SURGILENE | Davis & Geck, Inc. | 1988-03-01 |
| P810028S007 | DEKLENE(TM) | Deknatel, Inc. | 1988-02-22 |
| N16374S033 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1987-08-28 |
| N16374S032 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1987-06-18 |
| N17825S015 | SURGILENE | Davis & Geck, Inc. | 1987-06-05 |
| N16374S031 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1986-12-03 |
| N16374S030 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1986-05-23 |
| N16374S029 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1986-01-23 |
| N17825S014 | SURGILENE | Davis & Geck, Inc. | 1985-08-23 |
| N16374S028 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1985-06-10 |
| P810028S004 | DEKLENE(TM) | Deknatel, Inc. | 1985-02-27 |
| P810028S005 | DEKLENE(TM) | Deknatel, Inc. | 1984-12-17 |
| N16374S025 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1984-05-02 |
| N17825S013 | SURGILENE | Davis & Geck, Inc. | 1984-03-12 |
| N16374S027 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1984-03-12 |
| P810028S003 | DEKLENE(TM) | Deknatel, Inc. | 1983-12-23 |
| P810028S002 | DEKLENE(TM) | Deknatel, Inc. | 1983-11-17 |
| N17825S012 | SURGILENE | Davis & Geck, Inc. | 1983-06-30 |
| P810028S001 | DEKLENE(TM) | Deknatel, Inc. | 1983-06-22 |
| N16374S026 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1983-04-07 |
| N16374S024 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | ETHICON, Inc. | 1982-07-21 |
| N17825S011 | SURGILENE | Davis & Geck, Inc. | 1982-07-16 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ | Teleflex Medical, LLC | 2026-05-06 |
| K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | 2026-03-23 |
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026-02-19 |
| K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | 2025-10-22 |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | 2025-10-16 |
| K252225 | PowerKnot High Strength Sutures | Medacta International S.A. | 2025-09-12 |
| K252201 | HS Fiber | Riverpoint Medical | 2025-08-13 |
| K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025-03-27 |
| K241376 | HyperSuture All Blue Extension Line | Threadstone, LLC | 2024-08-09 |
| K234079 | HyperSuture Extension Line | Threadstone, LLC | 2024-05-10 |
| K231163 | HS Fiber Sutures | Riverpoint Medical | 2024-01-05 |
| K230311 | HyperSuture | Threadstone, LLC | 2023-11-24 |
| K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | 2023-08-25 |
| K223500 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | 2023-08-10 |
| K223122 | MENIX®; MENIX® DUO | S.B.M. Sas (Science & Bio Materials) | 2023-08-03 |
| K230510 | MyEllevate | Cynosure, LLC | 2023-07-06 |
| K213046 | AceConnex Pre-Sutured Fascia | Allosource | 2023-06-27 |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | Rti Surgical, Inc. | 2023-06-23 |
| K223822 | ACTIVBRAID™ | Embody, Inc. | 2023-06-02 |
| K220880 | Arthrex BioSuture | Arthrex, Inc. | 2022-10-27 |
| K222078 | Arthrex SoftStitch | Arthrex, Inc. | 2022-09-14 |
| K221354 | Arthrex SutureTape | Arthrex, Inc. | 2022-09-09 |
| K220186 | Zone Specific AIM | Conmed Corporation | 2022-05-13 |
| K220219 | PERMALOOP Suture, PERMATAPE Suture | Medos International SARL | 2022-04-26 |
| K212146 | Arthrex LoopLoc Knotless Suture | Arthrex, Inc. | 2021-10-25 |
| K210675 | EasyWhip | Winter Innovations, Inc. | 2021-05-03 |
| K203186 | DYNATAPE Suture | Medos International SARL | 2021-03-18 |
| K203393 | FAST-FIX FLEX | Smith & Nephew, Inc. | 2021-02-01 |
| K190707 | Arthrex SoftStitch | Arthrex, Inc. | 2020-10-02 |
| K202242 | HS Fiber | Riverpoint Medical, LLC | 2020-09-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07649990202174 | Geomax Reamer S-PI-A1.6 | Surgical Fusion Technologies GmbH | 2025-10-01 |
| 07649990202181 | Handpiece Front Cover | Surgical Fusion Technologies GmbH | 2024-01-10 |
| 07649990202020 | Tray_SF Push-In Anchor 2.3 | Surgical Fusion Technologies GmbH | 2024-01-10 |
| 07649990202150 | BoneWelder 150-W1 | Surgical Fusion Technologies GmbH | 2023-12-14 |
| 07649990202051 | Wrench 5.0 | Surgical Fusion Technologies GmbH | 2023-12-14 |
| 07649990202044 | Twist Drill PI-C 1.8 | Surgical Fusion Technologies GmbH | 2023-12-14 |
| 07649990202037 | Sonotrode PI-S 2.3 | Surgical Fusion Technologies GmbH | 2023-12-14 |
| 07649990202013 | Tray_SF Push-in Anchor 2.3 | Surgical Fusion Technologies GmbH | 2023-12-14 |
| 07649990202167 | SF Push-in Anchor 2.3 | Surgical Fusion Technologies GmbH | 2023-12-08 |
| 07613252495116 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327129649 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327095371 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327095418 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327095463 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327095470 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327096019 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327096033 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327096071 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327261493 | XBraid | STRYKER CORPORATION | 2015-11-19 |
| 07613327261509 | XBraid | STRYKER CORPORATION | 2015-11-19 |
| 07613327261516 | XBraid | STRYKER CORPORATION | 2015-11-19 |
| 07613327096125 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096088 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096095 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096170 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096163 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096149 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096132 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096118 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 10884521072602 | V-Loc | Covidien LP | 2015-09-02 |