Eder Instrument Co, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Eder Instrument Co, Inc.” (first 1979, latest 1984), across 9 product codes in 5 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| EMF | Knife, Surgical | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| EQN | Laryngoscope, Nasopharyngoscope | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | 1 | 1 |
| HXB | Probe | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (3)
- Ear, Nose and Throat (2)
- Obstetrics and Gynecology (2)
- Gastroenterology and Urology (1)
- Orthopedic (1)
Most recent Eder Instrument Co, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843498 | BIPOLAR SUCTION ELECTRODE | GET | 1984-12-14 | 99 |
| K843499 | ARTHROSCOPY LEG HOLDER | — | 1984-10-31 | 55 |
| K843497 | SURGICAL KNIVES & PROBES | EMF | 1984-10-31 | 55 |
| K831255 | LARYNGOSCOPE ATTACHMENT PH2000 | EQN | 1983-09-12 | 147 |
| K831240 | LASER BRONCHOSCOPE | EOQ | 1983-07-26 | 102 |
| K831241 | LASER LAPARAXOPE | HET | 1983-06-10 | 56 |
| K822959 | ENDOSCOPIC VIDEOSYSTEM | FET | 1982-10-22 | 17 |
| K802479 | SURGICAL KNIVES & PROBES | HXB | 1980-10-31 | 24 |
| K792100 | GRASPING FORCEP (W/FOUR PRONGS) | GEN | 1979-11-13 | 25 |
| K791052 | ENDOSCOPIC INSTRUMENT | HET | 1979-08-03 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Eder Instrument Co, 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 Eder Instrument Co, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Eder Instrument Co, Inc.” (first 1979, latest 1984), across 9 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 Eder Instrument Co, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eder Instrument Co, Inc. is 56 days.
Which FDA product codes appear under Eder Instrument Co, Inc.?
The most frequent FDA product codes under this applicant name are HET (Laparoscope, Gynecologic (And Accessories), 2); EMF (Knife, Surgical, 1); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Next steps
- See all 10 Eder Instrument Co, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HET, Eder Instrument Co, 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.