Steelex Sternum Set
FDA 510(k) K023411 · Aesculap, Inc.
510(k) numberK023411
Submission
- Device name
- Steelex Sternum Set
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- October 11, 2002
- Decision date
- December 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4495
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K170767 | Surgical Stainless Steel Suture, Stainless Steel SutureGAQ · Special | ETHICON, Inc. | 11/01/2017SE |
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| K082828 | Suturtek 360 Degree Sternal Closure DeviceGAQ · Special | Suturtek Incorporated | 10/14/2008SE |
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| K223596 | SQ.line KERRISONHAE · Traditional | 06/29/2023SE |
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| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
| K202124 | Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special | 09/02/2020SE |
Questions and answers
When was Steelex Sternum Set cleared by the FDA?
Steelex Sternum Set (K023411) received a 510(k) decision of Substantially Equivalent on December 19, 2002, 69 days after the submission was received.
What is the product code of K023411?
The FDA product code is GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, a Class II (moderate risk) device regulated under 21 CFR 878.4495.