The Sewing Source, Inc.: FDA clearances and approvals
The Sewing Source, Inc. has 9 FDA 510(k) clearances (first 1993, latest 1996), across 2 product codes in 1 review panel. Median 510(k) review time: 492 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYA | Gown, Surgical | 8 | 8 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
- General Hospital (9)
Most recent The Sewing Source, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960045 | ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE | KKX | 1996-06-05 | 155 |
| K921158 | O.R./SURGEONS GOWN, ITEM NO. 4950 | FYA | 1993-07-09 | 492 |
| K921157 | O.R./SURGEONS GOWN, ITEM NO. 4942 | FYA | 1993-07-09 | 492 |
| K921156 | O.R./SURGEONS GOWN, ITEM NO.4941 | FYA | 1993-07-09 | 492 |
| K921155 | O.R./SURGEONS GOWN, ITEM NO. 4962 | FYA | 1993-07-09 | 492 |
| K921154 | O.R./SURGEONS GOWN, ITEM NO. 4962 | FYA | 1993-07-09 | 492 |
| K921153 | O.R./SURGEONS GOWN, ITEM NO. 4960 | FYA | 1993-07-09 | 492 |
| K921152 | O.R./SURGEONS GOWN, ITEM NO. 4952 | FYA | 1993-07-09 | 492 |
| K921151 | O.R./SURGEONS GOWN, ITEM NO. 4951 | FYA | 1993-07-09 | 492 |
Recalls
openFDA lists no recalls under a recalling firm named The Sewing Source, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does The Sewing Source, Inc. have?
The Sewing Source, Inc. has 9 FDA 510(k) clearances (first 1993, latest 1996), across 2 product codes in 1 review panel.
How long does FDA take to clear The Sewing Source, Inc.'s 510(k)s?
The median time from FDA receipt to decision across The Sewing Source, Inc.'s cleared 510(k)s is 492 days.
What devices does The Sewing Source, Inc. make?
Its most frequent FDA product codes are FYA (Gown, Surgical, 8); KKX (Drape, Surgical, Antimicrobial, 1).
Has The Sewing Source, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching The Sewing Source, Inc. Related entities may recall under other names.
Next steps
- See all 9 The Sewing Source, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FYA, The Sewing Source, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.