Cutalon Nylon Polyamide Surgical Suture
FDA 510(k) K981322 · Genzyme Surgical Product (Genzyme Biosurgery)
510(k) numberK981322
Submission
- Device name
- Cutalon Nylon Polyamide Surgical Suture
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
Fall River, MA, US - Received
- April 10, 1998
- Decision date
- July 7, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAR – Suture, Nonabsorbable, Synthetic, Polyamide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5020
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261484 | Tissue Approximation SystemGAR · Special | Tas Medical, Inc. | 06/03/2026SE |
| K220980 | Tissue Approximation System (TAS)GAR · Traditional | Tas Medical, Inc. | 07/05/2023SE |
| K212888 | Golnit Nylon Monofilament SutureGAR · Abbreviated | Antarma, LLC Dba Golnit Sutures | 03/31/2022SE |
| K212603 | Non Absorbable Surgical Nylon SutureGAR · Traditional | Shandong Haidike Medical Product Co., Ltd. | 12/22/2021SE |
| K192420 | Crownjun Nylon SutureGAR · Traditional | Kono Seisakusho Co., Ltd. | 05/29/2020SE |
| K161633 | Rexlon, RexsilGAR · Traditional | Sm Eng Co., Ltd. | 03/02/2017SE |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureGAR · Traditional | Aesculap, Inc. | 02/17/2016SE |
| K152795 | RiverLon (Nylon) SutureGAR · Special | Riverpoint Medical | 10/28/2015SE |
| K123034 | Vital Sutures Suturex Cirugia Peruana SutumedGAR · Traditional | Unilene Sac | 05/28/2013SE |
| K081366 | Kumar T-Anchors Hernia SetGAR · Traditional | Nashville Surgical Instruments | 07/15/2008SE |
More from Nashville Surgical Instruments
| 510(k) | Device | Decision |
|---|---|---|
| K001440 | Nextstitch Cardiovascular Valve SutureGAT · Traditional | 11/13/2000SE |
| K001434 | 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical SutureGAT · Traditional | 06/12/2000SN |
| K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGAM · Traditional | 09/03/1999SE |
| K991416 | Endoscopic CameraGCJ · Traditional | 07/20/1999SE |
| K991191 | Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureGAM · Traditional | 06/22/1999SE |
| K990062 | SaphliftMDM · Traditional | 03/30/1999SE |
| K982712 | Rapid Transfer Blood Bag Model A-1650, Rapid Transfer Blood Bag Model S-250CAC · Traditional | 12/18/1998SE |
| K980016 | Millennium Valve Introducer/Rotator HandleMOP · Traditional | 08/07/1998SE |
Questions and answers
When was Cutalon Nylon Polyamide Surgical Suture cleared by the FDA?
Cutalon Nylon Polyamide Surgical Suture (K981322) received a 510(k) decision of Substantially Equivalent on July 7, 1998, 88 days after the submission was received.
What is the product code of K981322?
The FDA product code is GAR – Suture, Nonabsorbable, Synthetic, Polyamide, a Class II (moderate risk) device regulated under 21 CFR 878.5020.