Stephen Chakoff, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Stephen Chakoff, Inc.” (first 1993, latest 1995), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 10 | 10 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FCW | Light Source, Fiberoptic, Routine | 1 | 1 |
| FDG | Retractor, Fiberoptic | 1 | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
Review panels
- General and Plastic Surgery (12)
- Gastroenterology and Urology (2)
- Ear, Nose and Throat (1)
- Obstetrics and Gynecology (1)
Most recent Stephen Chakoff, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940316 | HYSTERSCOPE | HIH | 1995-11-16 | 661 |
| K940317 | SINUSCOPE | EOB | 1995-05-24 | 485 |
| K950753 | CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO | GCJ | 1995-05-15 | 87 |
| K951082 | CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE | GCJ | 1995-03-22 | 13 |
| K950748 | CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE) | GCJ | 1995-03-06 | 17 |
| K950747 | CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) | GCJ | 1995-03-06 | 17 |
| K950746 | CHAKOFF ENDOSCOPY (SET LAPAROSCOPY) | GCJ | 1995-03-06 | 17 |
| K950745 | CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES) | GCJ | 1995-03-06 | 17 |
| K950744 | CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE) | GCJ | 1995-03-06 | 17 |
| K945421 | CHAKOFF ENDOSCOPY | FDG | 1994-12-23 | 49 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Stephen Chakoff, 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.
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.
- Stephen A. Dunn, Inc. (2 510(k)s)
- Stephen M Koral, Dmd (2 510(k)s)
- Stephen J Harkins, Dds, PC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stephen Chakoff, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Stephen Chakoff, Inc.” (first 1993, latest 1995), across 7 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 Stephen Chakoff, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stephen Chakoff, Inc. is 68 days.
Which FDA product codes appear under Stephen Chakoff, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 10); EOB (Nasopharyngoscope (Flexible Or Rigid), 1); FCW (Light Source, Fiberoptic, Routine, 1).
Next steps
- See all 16 Stephen Chakoff, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Stephen Chakoff, 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.