Hgm, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Hgm, Inc.” (first 1983, latest 1995), across 8 product codes in 6 review panels. Median 510(k) review time under this name: 69 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 6 | 6 |
| HQF | Laser, Ophthalmic | 6 | 6 |
| LNK | Laser For Gastro-Urology Use | 2 | 2 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
| HJM | Transilluminator, Ac-Powered | 1 | 1 |
| LLF | Laser, Neurosurgical, Argon | 1 | 1 |
| LMS | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (7)
- General and Plastic Surgery (6)
- Gastroenterology and Urology (2)
- Ear, Nose and Throat (1)
- Neurology (1)
- Obstetrics and Gynecology (1)
Most recent Hgm, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950120 | SMART PLUG | GEX | 1995-08-11 | 211 |
| K931072 | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | HJM | 1994-11-10 | 618 |
| K931784 | HGM ILLUMINATING IMAGING ENDOCULAR PROBE | HQF | 1994-03-01 | 326 |
| K933333 | HGM SCANMAN PLUS | GEX | 1993-09-23 | 77 |
| K931499 | Q-11 OPHTHALMIC LASER | GEX | 1993-08-19 | 147 |
| K925663 | HGM ASPIRATING ENDOOCULAR(TM) PROBE | HQF | 1993-08-17 | 280 |
| K930543 | E-25 KRYPTON ION LASER (SURGICA K5) | GEX | 1993-06-22 | 140 |
| K880908 | MODEL PC ARGON LASER | GEX | 1988-05-03 | 61 |
| K873773 | ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER | GEX | 1987-10-13 | 27 |
| K872630 | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | LNK | 1987-08-25 | 50 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hgm, 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 Hgm, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Hgm, Inc.” (first 1983, latest 1995), across 8 product codes in 6 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 Hgm, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hgm, Inc. is 69 days.
Which FDA product codes appear under Hgm, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 6); HQF (Laser, Ophthalmic, 6); LNK (Laser For Gastro-Urology Use, 2).
Next steps
- See all 23 Hgm, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Hgm, 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.