Scholten Surgical Instruments, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Scholten Surgical Instruments, Inc.” (first 1985, latest 2007), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| BWN | Table And Attachments, Operating-Room | 1 | 1 |
| DTB | Permanent Pacemaker Electrode | 1 | 1 |
| DWZ | Device, Biopsy, Endomyocardial | 1 | 1 |
| FOX | Stand, Infusion | 1 | 1 |
| GAD | Retractor | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| JEB | Table, Surgical With Orthopedic Accessories, Manual | 1 | 1 |
Review panels
Most recent Scholten Surgical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072051 | NOVATOME, MODEL: SU101-50 | DWZ | 2007-10-03 | 69 |
| K900405 | SCHOLTEN FRAME | JEB | 1990-03-01 | 31 |
| K852331 | SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC | IZI | 1986-08-01 | 427 |
| K852119 | TEMPORARY PACEMAKER GROUND WIRE | DTB | 1985-09-15 | 123 |
| K852332 | TABLE ACCESSORIES, OPERATING ROOM | BWN | 1985-07-02 | 32 |
| K852120 | FORCEPS, BIOPSY(NON RIGID) | GEN | 1985-07-02 | 48 |
| K852330 | RETRACTOR, SURGICAL | GAD | 1985-06-27 | 27 |
| K852329 | STAND, OPERATING ROOM | FOX | 1985-06-14 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Scholten Surgical Instruments, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Scholten Surgical Instruments, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Scholten Surgical Instruments, Inc.” (first 1985, latest 2007), across 8 product codes in 4 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 Scholten Surgical Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scholten Surgical Instruments, Inc. is 40 days.
Which FDA product codes appear under Scholten Surgical Instruments, Inc.?
The most frequent FDA product codes under this applicant name are BWN (Table And Attachments, Operating-Room, 1); DTB (Permanent Pacemaker Electrode, 1); DWZ (Device, Biopsy, Endomyocardial, 1).
Next steps
- See all 8 Scholten Surgical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BWN, Scholten Surgical Instruments, 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.