Aesculap Instruments Corp.: FDA clearances and approvals
Aesculap Instruments Corp. has 13 FDA 510(k) clearances (first 1977, latest 1990), across 12 product codes in 6 review panels. Median 510(k) review time: 36 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 |
|---|---|---|---|
| DZA | Drill, Dental, Intraoral | 2 | 2 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 1 |
| DWQ | Stripper, Vein, External | 1 | 1 |
| EJL | Bur, Dental | 1 | 1 |
| FLE | Sterilizer, Steam | 1 | 1 |
| GAD | Retractor | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| HBO | Clip, Scalp | 1 | 1 |
| HCH | Clip, Aneurysm | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Plus 2 more product codes.
Review panels
- Dental (3)
- General Hospital (3)
- Cardiovascular (2)
- Neurology (2)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Aesculap Instruments Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890182 | PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV | DSY | 1990-02-28 | 406 |
| K885046 | INSITUCAT VALVE STRIPPER | DWQ | 1990-02-28 | 450 |
| K890443 | CASPAR SCALP CLIP, APPLIER | HBO | 1989-06-15 | 139 |
| K893121 | ROBOTRAC (TM) RETRACTOR ARM | GAD | 1989-06-01 | 37 |
| K884057 | ELAN-E DISPOSABLE DRAPE | KKX | 1988-10-19 | 23 |
| K880704 | CERULLO SUCTION REGULATOR | GCX | 1988-03-29 | 36 |
| K860016 | AESCULAP BONE MILL | LYS | 1986-03-19 | 75 |
| K801888 | HANDPIECE, DENTAL | DZA | 1980-08-20 | 23 |
| K801887 | DRILL, DENTAL | DZA | 1980-08-20 | 23 |
| K801886 | BURR, DENTAL | EJL | 1980-08-20 | 23 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aesculap Instruments Corp..
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 Aesculap Instruments Corp. have?
Aesculap Instruments Corp. has 13 FDA 510(k) clearances (first 1977, latest 1990), across 12 product codes in 6 review panels.
How long does FDA take to clear Aesculap Instruments Corp.'s 510(k)s?
The median time from FDA receipt to decision across Aesculap Instruments Corp.'s cleared 510(k)s is 36 days.
What devices does Aesculap Instruments Corp. make?
Its most frequent FDA product codes are DZA (Drill, Dental, Intraoral, 2); DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 1); DWQ (Stripper, Vein, External, 1).
Has Aesculap Instruments Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Aesculap Instruments Corp. Related entities may recall under other names.
Next steps
- See all 13 Aesculap Instruments Corp. clearances with predicates and recalls
- Run predicate analysis for product code DZA, Aesculap Instruments Corp.'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.