# The Sewing Source, Inc.

- Location (FDA's records): Spring Hope, NC
- FDA decisions: 9 (1993–1996): 9 510(k) clearances
- Product codes: FYA (8), KKX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K960045: Envirotex Reusable O.R. Wrapper and Custom Surgical Drape (Jun 5, 1996)
- K921156: O.R./Surgeons Gown, Item NO.4941 (Jul 9, 1993)
- K921152: O.R./Surgeons Gown, Item NO. 4952 (Jul 9, 1993)
- K921157: O.R./Surgeons Gown, Item NO. 4942 (Jul 9, 1993)
- K921158: O.R./Surgeons Gown, Item NO. 4950 (Jul 9, 1993)
- K921155: O.R./Surgeons Gown, Item NO. 4962 (Jul 9, 1993)
- K921154: O.R./Surgeons Gown, Item NO. 4962 (Jul 9, 1993)
- K921151: O.R./Surgeons Gown, Item NO. 4951 (Jul 9, 1993)

Source page: https://510kreport.com/company/sewing-source