The Sewing Source, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What The Sewing Source, Inc. makes
The company manufactures reusable and disposable surgical gowns and drapes designed for operating room use, including custom surgical drapes and reusable OR wrappers. These products are intended to provide barrier protection for surgeons and surgical teams during procedures.
The portfolio consists of Class II devices, authorised via the FDA’s 510(k) pathway. Products are listed under the FDA’s regulatory registry and are based in the United States.
Catalogue
O.R./Surgeons Gown, Item No. 4962 Ref K921155
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
O.R./Surgeons Gown, Item No. 4950 Ref K921158
Regimes: 510(k) Registry: 510(k)O.R./Surgeons Gown, Item NO.4941 Ref K921156
Regimes: 510(k) Registry: 510(k)O.R./Surgeons Gown, Item No. 4960 Ref K921153
Regimes: 510(k) Registry: 510(k)O.R./Surgeons Gown, Item No. 4952 Ref K921152
Regimes: 510(k) Registry: 510(k)O.R./Surgeons Gown, Item No. 4962 Ref K921154
Regimes: 510(k) Registry: 510(k)O.R./Surgeons Gown, Item No. 4942 Ref K921157
Regimes: 510(k) Registry: 510(k)O.R./Surgeons Gown, Item No. 4951 Ref K921151
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does The Sewing Source, Inc. have in the registry?
The registry currently lists 9 devices for The Sewing Source, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Sewing Source, Inc.'s devices?
Among its 9 most recently registered devices, The Sewing Source, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do The Sewing Source, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for The Sewing Source, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from The Sewing Source, Inc. in the registry?
The most recently registered devices listed for The Sewing Source, Inc. include O.R./SURGEONS GOWN, ITEM NO. 4962, ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE, O.R./SURGEONS GOWN, ITEM NO. 4950 and O.R./SURGEONS GOWN, ITEM NO.4941.