Percutaneous Systems, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under 2 spellings of the applicant name “Percutaneous Systems, Inc.” (first 2004, latest 2011), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | 5 | 5 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 3 | 3 |
| EZD | Catheter, Straight | 2 | 2 |
| LQR | Dislodger, Stone, Biliary | 1 | 1 |
Review panels
Most recent Percutaneous Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102887 | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 | FFL | 2011-05-16 | 228 |
| K090485 | COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 | LQR | 2009-07-22 | 147 |
| K082803 | COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 | FFL | 2008-11-13 | 50 |
| K061766 | EXPRESSWAY INTERMITTENT CATHETER | EZD | 2007-03-09 | 260 |
| K052298 | CYSTOGLIDE INTRODUCER SHEATH | KNY | 2006-12-12 | 476 |
| K052134 | CYSTOGLIDE DILATING INTRODUCER SHEATH | KNY | 2005-09-22 | 48 |
| K052048 | ACCORDION | FFL | 2005-09-13 | 46 |
| K042531 | UPDATED SLIP UROLOGY INTRODUCER SHEATH | KNY | 2005-02-01 | 137 |
| K042877 | MICROVERTER URETERAL ACCESS SHEATH | KNY | 2004-11-16 | 29 |
| K040520 | SLIP UROLOGY INTRODUCER SHEATH | KNY | 2004-05-20 | 83 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Percutaneous Systems, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Percutaneous Systems, Inc. (6)
- Percutaneous Systems, Incorporated (5)
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.
- Percutaneous Technologies (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Percutaneous Systems, Inc.?
FDA lists 11 510(k) clearances under 2 spellings of the applicant name “Percutaneous Systems, Inc.” (first 2004, latest 2011), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Percutaneous Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Percutaneous Systems, Inc. is 83 days.
Which FDA product codes appear under Percutaneous Systems, Inc.?
The most frequent FDA product codes under this applicant name are KNY (Accessories, Catheter, G-U, 5); FFL (Dislodger, Stone, Basket, Ureteral, Metal, 3); EZD (Catheter, Straight, 2).
Next steps
- See all 11 Percutaneous Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNY, Percutaneous Systems, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.