Peters Surgical: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Peters Surgical” (first 2005, latest 2024), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 261 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 | 2 | 358 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Peters Surgical took a median 358 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 3 | 3 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
| KRH | Ring, Annuloplasty | 1 | 1 |
| MXW | Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) | 1 | 1 |
Review panels
Most recent Peters Surgical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233265 | Monotime and Optime R | GAM | 2024-10-11 | 378 |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | GAM | 2024-07-12 | 339 |
| K071281 | UNIRING - ANNULOPLASTY RING WITH SIZERS | KRH | 2007-08-03 | 88 |
| K060465 | PREMIO | MXW | 2007-01-17 | 329 |
| K060163 | CARDIOFLON, CARDIOXYL | GAT | 2006-10-11 | 261 |
| K062366 | OPTIME, SINUSORB PGA | GAM | 2006-10-02 | 49 |
| K052701 | COROLENE | GAW | 2005-12-13 | 76 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-06-25.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Peters Surgical?
FDA lists 7 510(k) clearances under the applicant name “Peters Surgical” (first 2005, latest 2024), across 5 product codes in 2 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 Peters Surgical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Peters Surgical is 261 days.
Which FDA product codes appear under Peters Surgical?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 3); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 1); GAW (Suture, Nonabsorbable, Synthetic, Polypropylene, 1).
Next steps
- See all 7 Peters Surgical clearances with predicates and recalls
- Run predicate analysis for product code GAM, Peters Surgical'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.