Surgilon, Dermalon, & Ophthalon
FDA 510(k) K981582 · Davis & Geck, Inc.
510(k) numberK981582
Submission
- Device name
- Surgilon, Dermalon, & Ophthalon
- Applicant
- Davis & Geck, Inc.
Hazlewood, MO, US - Received
- May 4, 1998
- Decision date
- July 13, 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
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| 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 |
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|---|---|---|
| K982853 | Silk SutureGAP · Traditional | 04/30/1999SN |
| K980610 | Dexon Rapid (Dexon R)GAM · Traditional | 05/18/1998SE |
| K974015 | Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick-…FOZ · Traditional | 05/18/1998SE |
| K980062 | Monojectt Bluntip I.V. Access Cannula with Vial Access Pin DeviceFMI · Traditional | 03/20/1998SE |
| K973409 | Kangaroo Enteral Feeding Extension Set for Syringe PumpsKNT · Traditional | 02/27/1998SE |
| K970857 | Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit and Optional Argyle…CAC · Traditional | 11/05/1997SE |
| K972139 | Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope…BTM · Traditional | 09/03/1997SE |
| K972566 | Dexon VioletGAM · Traditional | 08/14/1997SE |
| K962971 | Polypropylene Mesh (Various Sizes)FTL · Traditional | 09/16/1996SE |
| K955722 | Flexon Temporary Cardiac Pacer LeadLDF · Traditional | 03/15/1996SE |
Questions and answers
When was Surgilon, Dermalon, & Ophthalon cleared by the FDA?
Surgilon, Dermalon, & Ophthalon (K981582) received a 510(k) decision of Substantially Equivalent on July 13, 1998, 70 days after the submission was received.
What is the product code of K981582?
The FDA product code is GAR – Suture, Nonabsorbable, Synthetic, Polyamide, a Class II (moderate risk) device regulated under 21 CFR 878.5020.