Heraeus Surgical, Inc.: FDA clearances and approvals
Heraeus Surgical, Inc. has 8 FDA 510(k) clearances (first 1994, latest 1996), across 2 product codes in 1 review panel. Median 510(k) review time: 77 days.
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 | 7 | 7 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Heraeus Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960636 | LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER | GEX | 1996-08-21 | 189 |
| K955734 | LASERSONICS PARASCAN DOSIMETER DEVICE | GEX | 1996-02-13 | 57 |
| K953917 | LASESONICS LOW POWER CO2 LASER SYSTEM | GEX | 1995-10-26 | 66 |
| K951215 | LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER | GEX | 1995-04-18 | 32 |
| K943716 | LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES | GEX | 1995-03-14 | 225 |
| K944346 | LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIES | GEX | 1994-11-08 | 63 |
| K935604 | LASERSONICS TISSUE MORCELLATOR SET | GCJ | 1994-03-23 | 124 |
| K935775 | LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS | GEX | 1994-03-01 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Heraeus Surgical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Heraeus Surgical, Inc. have?
Heraeus Surgical, Inc. has 8 FDA 510(k) clearances (first 1994, latest 1996), across 2 product codes in 1 review panel.
How long does FDA take to clear Heraeus Surgical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Heraeus Surgical, Inc.'s cleared 510(k)s is 77 days.
What devices does Heraeus Surgical, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 7); GCJ (Laparoscope, General & Plastic Surgery, 1).
Has Heraeus Surgical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Heraeus Surgical, Inc. Related entities may recall under other names.
Next steps
- See all 8 Heraeus Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Heraeus Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.