Atlas FDA

STRYKER T4 HYTREL TOGA

FDA 510(k) clearance K070078 · decided 2007-02-02

Clearance details

K-number
K070078
Device name
STRYKER T4 HYTREL TOGA
Applicant
Stryker Instruments, Instruments Div.
Decision
Substantially Equivalent
Date received
2007-01-09
Decision date
2007-02-02
Days to decision
24 days
Clearance type
Special
Product code
FYA
Device class
2
Regulation number
878.4040
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Stryker Instruments

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) (K261028)Yadu Medical (Henan) Co., Ltd.2026-08-07
NYES Tuff Cuff L3 Disposable Gowns (K261949)New York Embroidery Studio2026-07-10
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (K252575)New York Embroidery Studio (NYES)2026-06-04
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (K260725)Hindernis DE Mexico, S.A.P.I. DE C.V.2026-05-12
Cardinal Health™ Poly Reinforced Surgical Gown (K253243)Cardinal Health 200, LLC2026-04-28
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) (K253003)Hubei Xinxin Non-Woven Co., Ltd.2026-04-20
Copioumed AAMI 3 Surgical Gown (K251860)Copioumed International, Inc.2026-02-26
Henan Yadu Level 4 Surgical Gowns (Reinforced) (K252301)Yadu Medical (Henan) Co., Ltd.2026-02-04
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (K250564)Yadu Medical (Henan) Co., Ltd.2025-12-03
ViVi® Toga Premium (K243522)Thi Total Healthcare Innovation GmbH2025-05-30
Dream Medi Sterile Surgical Gown (SurgicalGownUL) (K242937)Dae Myung Chemical Co., Ltd. (Vietnam)2025-05-05
Medline Level 4 Surgical Gown with Breathable Sleeves (K242844)Medline Industries, LP2025-02-26

Recalls involving this device

RecordFirmDate
Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product U recall (Z-1489-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product U recall (Z-1490-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. recall (Z-1491-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Produc recall (Z-1492-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product recall (Z-1493-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Prod recall (Z-1494-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usa recall (Z-1495-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usa recall (Z-1496-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; recall (Z-1497-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product U recall (Z-1498-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Pr recall (Z-1499-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Produc recall (Z-1500-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product recall (Z-1501-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Produ recall (Z-1502-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Pro recall (Z-1503-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06
Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; P recall (Z-1504-2013)Stryker Instruments Div. of Stryker Corporation2013-06-06