American Silk Sutures, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “American Silk Sutures, Inc.” (first 1985, latest 1992), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 36 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HBA | Neurosurgical Paddie | 4 | 4 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 3 | 3 |
| EFQ | Gauze/Sponge, Internal | 2 | 2 |
| EFN | Cotton, Roll | 1 | 1 |
| EPP | Splint, Nasal | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | 1 | 1 |
| KME | Bedding, Disposable, Medical | 1 | 1 |
Review panels
- General and Plastic Surgery (7)
- Neurology (4)
- Dental (1)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent American Silk Sutures, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922143 | AMERICAN BURN SHEET | KME | 1992-08-10 | 96 |
| K904514 | STRUNG TELFA NON-ADHERENT SPONGE | HBA | 1991-03-27 | 176 |
| K902921 | RAYON NEUROLOGICAL SPONGE | HBA | 1990-09-18 | 77 |
| K872810 | STRUNG DENTAL ROLLS | EFN | 1987-12-04 | 143 |
| K872951 | AMERICAN BRAIN RETRACTOR COVER | GET | 1987-09-16 | 50 |
| K872905 | AMERICAN NASAL SPONGE | EPP | 1987-09-04 | 42 |
| K872906 | SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE | GEA | 1987-08-11 | 18 |
| K872809 | GAUZE CHERRY SPONGE | GDY | 1987-08-04 | 21 |
| K872808 | CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 | EFQ | 1987-08-04 | 21 |
| K872807 | NON-WOVEN TRACHEOTOMY SPONGE | GDY | 1987-08-04 | 21 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Silk Sutures, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Silk Sutures, Inc.?
FDA lists 14 510(k) clearances under the applicant name “American Silk Sutures, Inc.” (first 1985, latest 1992), across 8 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American Silk Sutures, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Silk Sutures, Inc. is 36 days.
Which FDA product codes appear under American Silk Sutures, Inc.?
The most frequent FDA product codes under this applicant name are HBA (Neurosurgical Paddie, 4); GDY (Gauze/Sponge, Internal, X-Ray Detectable, 3); EFQ (Gauze/Sponge, Internal, 2).
Next steps
- See all 14 American Silk Sutures, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HBA, American Silk Sutures, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.