Gm Engineering, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Gm Engineering, Inc.” (first 1993, latest 1995), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 140 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 |
|---|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | 2 | 2 |
| FDC | Resectoscope, Working Element | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| KAR | Irrigator, Sinus | 1 | 1 |
| KYH | Endoscope, Ophthalmic | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 1 |
Review panels
- General and Plastic Surgery (4)
- Ear, Nose and Throat (3)
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (1)
- Ophthalmic (1)
Most recent Gm Engineering, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953348 | ARTICULATING RETRACTOR TISSUE RETRACTORS | GCJ | 1995-09-12 | 57 |
| K942626 | CONTINUOUS FLOW BIOPSY PROBE | FDC | 1995-05-30 | 362 |
| K932394 | BERNSTEIN(TM) UTERINE MANIPULATOR | LKF | 1995-01-26 | 618 |
| K941661 | GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT | EQH | 1994-08-23 | 140 |
| K942703 | GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA | GCJ | 1994-08-19 | 72 |
| K941662 | GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT | EQH | 1994-07-20 | 106 |
| K941660 | GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT | KYH | 1994-05-24 | 49 |
| K933962 | GM CONTINUOUS FLOW BIOPSY PROBE | FDC | 1994-02-25 | 196 |
| K934035 | GM MONOPOLAR/FRAZIER SUCTION PROBE | GEI | 1993-12-01 | 105 |
| K930611 | TRUE FLOW(TM) VALVE | GEX | 1993-12-01 | 299 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gm Engineering, 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 Gm Engineering, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Gm Engineering, Inc.” (first 1993, latest 1995), across 8 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 Gm Engineering, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gm Engineering, Inc. is 140 days.
Which FDA product codes appear under Gm Engineering, Inc.?
The most frequent FDA product codes under this applicant name are EQH (Source, Carrier, Fiberoptic Light, 2); FDC (Resectoscope, Working Element, 2); GCJ (Laparoscope, General & Plastic Surgery, 2).
Next steps
- See all 11 Gm Engineering, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EQH, Gm Engineering, 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.