Cottony II, Silky II Polydek & Tevdek II Polyester Suture
FDA 510(k) K021019 · Genzyme Corp.
510(k) numberK021019
Submission
- Device name
- Cottony II, Silky II Polydek & Tevdek II Polyester Suture
- Applicant
- Genzyme Corp.
Fall River, MA, US - Received
- March 29, 2002
- Decision date
- June 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
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| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
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Questions and answers
When was Cottony II, Silky II Polydek & Tevdek II Polyester Suture cleared by the FDA?
Cottony II, Silky II Polydek & Tevdek II Polyester Suture (K021019) received a 510(k) decision of Substantially Equivalent on June 18, 2002, 81 days after the submission was received.
What is the product code of K021019?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.