510(k) K043004
- Device
- STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
- Applicant
- VIASYS MEDSYSTEMS
- 510(k) number
- K043004
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-16
- Date received
- 2004-11-01
- Regulation
- 878.4040
- Classification name
- Gown, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHANIE WASIELEWSKI
- Address
- 100 Chaddick Dr. Wheeling IL US 60090 60090
FDA Registration Numbers#
- 1123137
- 3009750712
- 3016509375
- 3034669683
- 3017171460
- 3038718579
- 3006723155
- 9680887
- 3026536498
- 9680794
- 2431166
- 3005595283
- 3015967359
- 3009114792
- 3006437555
- 1061124
- 3014159736
- 3016680721
- 8043817
- 3017910185
- 1065597
- 3012595397
- 3010041511
- 3008559312
- 3005142514
- 3010432890
- 3008729549
- 3012811961
- 1526350
- 3007082897
- 3010131137
- 3013525704
- 3015859709
- 3013429557
- 3015173212
- 3004111573
- 3031982537
- 3008824097
- 2030624
- 3014315560
- 3013443304
- 3003495693
- 3012344767
- 3036773433
- 3012268821
- 3016844398
- 3001124136
- 3034204758
- 9616876
- 2320762
- 1054241
- 3020163307
- 3015895045
- 3017467279
- 3012497308
- 3014666579
- 2183744
- 3009443860
- 3015068387
- 3006400329
- 3013960812
- 3014925393
- 3011500469
- 1047429
- 3032507796
- 3010807315
- 3003348807
- 3015960676
- 1928237
- 1836161
- 3021274073
- 3007344957
- 3004713352
- 3002807090
- 3027977504
- 3004513970
- 3043226252
- 1319639
- 3006973666
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FYA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026-05-12 |
| K253243 | Cardinal Health™ Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | 2026-04-28 |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | Hubei Xinxin Non-Woven Co., Ltd. | 2026-04-20 |
| K251860 | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | 2026-02-26 |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. | 2026-02-04 |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2025-12-03 |
| K243522 | ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH | 2025-05-30 |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) | 2025-05-05 |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP | 2025-02-26 |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Instruments | 2024-10-16 |
| K241214 | ProPel SG3™ Surgical Gown | Standard Textile Co., Inc. | 2024-09-10 |
| K233571 | GCI Surgical Gown | George Courey, Inc. | 2024-08-02 |
| K233068 | Disposable Surgical Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2024-03-29 |
| K233183 | Surgical Gown (40083) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2024-02-01 |
| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | 2023-10-12 |
Legacy Summary#
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FDA Review#
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