Snowden-Pencer: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Snowden-Pencer” (first 1986, latest 1996), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | 1 | 1 |
| HEI | Monitor, Heart-Valve Movement, Fetal, Ultrasonic | 1 | 1 |
| HFI | Coagulator, Culdoscopic (And Accessories) | 1 | 1 |
Review panels
Most recent Snowden-Pencer 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960400 | DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) | FBM | 1996-03-12 | 43 |
| K930666 | REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY | GEI | 1994-05-19 | 464 |
| K930667 | REUSABLE LAPAROSCOPIC INSTRUMENTS | GCJ | 1994-05-16 | 461 |
| K924148 | DIAMOND-SHARP(R) TROCARS | HFI | 1994-02-28 | 559 |
| K924149 | ENDO I/A PROBE | GCJ | 1993-01-26 | 161 |
| K920985 | SNOWDEN-PENCER IRRIGATION PUMP | HEI | 1992-06-09 | 99 |
| K920986 | SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700 | HIF | 1992-06-04 | 94 |
| K913979 | ENDO I/A Y SET | HIF | 1991-11-27 | 82 |
| K913835 | SNOWDEN-PENCER INSUFFLATOR TUBING SET | HIF | 1991-11-07 | 73 |
| K861372 | ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY | GEI | 1986-06-19 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named Snowden-Pencer.
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 Snowden-Pencer?
FDA lists 10 510(k) clearances under the applicant name “Snowden-Pencer” (first 1986, latest 1996), across 6 product codes in 3 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 Snowden-Pencer?
The median time from FDA receipt to decision across 510(k)s cleared under the name Snowden-Pencer is 96 days.
Which FDA product codes appear under Snowden-Pencer?
The most frequent FDA product codes under this applicant name are HIF (Insufflator, Laparoscopic, 3); GCJ (Laparoscope, General & Plastic Surgery, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 10 Snowden-Pencer clearances with predicates and recalls
- Run predicate analysis for product code HIF, Snowden-Pencer'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.