T. Korossurgical Instruments Corp.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “T. Korossurgical Instruments Corp.” (first 1985, latest 2001), across 14 product codes in 4 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 |
|---|---|---|---|
| GAD | Retractor | 8 | 8 |
| HRX | Arthroscope | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 2 | 2 |
| BWN | Table And Attachments, Operating-Room | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| FWW | Table, Operating-Room, Pneumatic | 1 | 1 |
| FZS | Curette, Surgical, General Use | 1 | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 1 |
| HTZ | Instrument, Cutting, Orthopedic | 1 | 1 |
Plus 4 more product codes.
Review panels
- General and Plastic Surgery (16)
- Orthopedic (7)
- Cardiovascular (2)
- Neurology (2)
Most recent T. Korossurgical Instruments Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001915 | GRAFT MARKER RING | MAB | 2001-04-27 | 308 |
| K002755 | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | LRN | 2000-12-04 | 90 |
| K954016 | VIDEOSCOPE W/IRRIGATION SHEATH | HRX | 1996-01-25 | 153 |
| K953998 | DISCETOME TISSUE ASPIRATOR | HRX | 1995-12-04 | 102 |
| K954052 | ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES | HRX | 1995-11-06 | 69 |
| K954014 | PERCUTANEOUS DISCECTOMY CANNULA SYSTEM | HRX | 1995-11-06 | 73 |
| K935529 | CERVICAL SELF-RETAINING RETRACTOR | GZT | 1994-03-22 | 126 |
| K931262 | REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR | GCJ | 1993-08-06 | 151 |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | GAD | 1993-08-06 | 322 |
| K926583 | REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR | GCJ | 1993-08-06 | 322 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named T. Korossurgical Instruments Corp..
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 T. Korossurgical Instruments Corp.?
FDA lists 27 510(k) clearances under the applicant name “T. Korossurgical Instruments Corp.” (first 1985, latest 2001), across 14 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 T. Korossurgical Instruments Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name T. Korossurgical Instruments Corp. is 69 days.
Which FDA product codes appear under T. Korossurgical Instruments Corp.?
The most frequent FDA product codes under this applicant name are GAD (Retractor, 8); HRX (Arthroscope, 4); GCJ (Laparoscope, General & Plastic Surgery, 3).
Next steps
- See all 27 T. Korossurgical Instruments Corp. clearances with predicates and recalls
- Run predicate analysis for product code GAD, T. Korossurgical Instruments Corp.'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.