Stryker T4 Hytrel Toga
FDA 510(k) K070078 · Stryker Instruments, Instruments Div.
510(k) numberK070078
Submission
- Device name
- Stryker T4 Hytrel Toga
- Applicant
- Stryker Instruments, Instruments Div.
Kalamazoo, MI, US - Received
- January 9, 2007
- Decision date
- February 2, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FYA – Gown, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
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| K252575 | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)FYA · Traditional | New York Embroidery Studio (NYES) | 06/04/2026SE |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)FYA · Traditional | Hindernis DE Mexico, S.A.P.I. DE C.V. | 05/12/2026SE |
| K253243 | Cardinal Health Poly Reinforced Surgical GownFYA · Abbreviated | Cardinal Health 200, LLC | 04/28/2026SE |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…FYA · Traditional | Hubei Xinxin Non-Woven Co., Ltd. | 04/20/2026SE |
| K251860 | Copioumed AAMI 3 Surgical GownFYA · Traditional | Copioumed International, Inc. | 02/26/2026SE |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 02/04/2026SE |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 12/03/2025SE |
More from Yadu Medical (Henan) Co., Ltd.
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| K123178 | Stryker Venom Electrodes and CannulaeGXI · Traditional | 03/28/2013SE |
| K113477 | Ivas 20MM (10 Gauge) Balloon CatheterNDN · Traditional | 01/06/2012SE |
| K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM(10 GAUGE)0705-115-500, Ivas…NDN · Traditional | 03/18/2010SE |
| K072702 | Stryker Antimic CatheterBSO · Traditional | 03/19/2008SE |
| K073017 | Stryker Stri-Shield Flyte TogasFYA · Special | 11/30/2007SE |
Questions and answers
When was Stryker T4 Hytrel Toga cleared by the FDA?
Stryker T4 Hytrel Toga (K070078) received a 510(k) decision of Substantially Equivalent on February 2, 2007, 24 days after the submission was received.
What is the product code of K070078?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.