Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)
FDA 510(k) K980988 · Axya Medical, Inc.
510(k) numberK980988
Submission
- Device name
- Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)
- Applicant
- Axya Medical, Inc.
Marblehead, MA, US - Received
- March 17, 1998
- Decision date
- May 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAB – Needle, Suturing, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K932591 | Endo-JudgeGAB · Traditional | Synergistic Medical Technologies, Inc. | 12/22/1993SE |
| K895681 | Contrast Background MaterialGAB · Traditional | Applied Medical Technologies | 10/24/1989SE |
| K863595 | Coated Suture NeedleGAB · Traditional | Sharpoint, Inc. | 10/24/1986SE |
| K831648 | Anchor Brand Surgical NeedlesGAB · Traditional | Anchor Products Co. | 08/16/1983SE |
| K812444 | Radiation Sterilization for Needle CNTRGAB · Traditional | Devon Industries, Inc. | 12/14/1981SE |
| K801976 | Scanlan Sternum Needle-SutureGAB · Traditional | Scanlan Intl., Inc. | 09/26/1980SE |
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| K070773 | Axya, Model 3000 Axyzloop Titanium Bone AnchorMBI · Traditional | 10/11/2007SE |
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| K063194 | Tufflex Polyester SutureGAT · Special | 12/04/2006SE |
| K060165 | Axyaflex Polyester SutureGAT · Traditional | 09/01/2006SE |
| K060970 | Axyaloop Nonabsorbable Bone AnchorJDR · Traditional | 07/05/2006SE |
| K052491 | Axya Model 6500 Axyaloop Self-Tapping Bone AnchorMBI · Special | 10/07/2005SE |
| K051983 | Model 3000 Axyaloop Bio-Absorbable Bone AnchorMAI · Special | 08/05/2005SE |
| K051250 | Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorMAI · Special | 06/09/2005SE |
| K041698 | Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorMAI · Traditional | 10/05/2004SE |
| K022207 | Axya Model 3000 Axyaloop Titanium Bone Anchor SystemMBI · Traditional | 10/04/2002SE |
Questions and answers
When was Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls) cleared by the FDA?
Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls) (K980988) received a 510(k) decision of Substantially Equivalent on May 11, 1998, 55 days after the submission was received.
What is the product code of K980988?
The FDA product code is GAB – Needle, Suturing, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.