Tava Surgical Instruments: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Tava Surgical Instruments” (first 1986, latest 1994), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 3 | 3 |
| FQH | Lavage, Jet | 1 | 1 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
Review panels
Most recent Tava Surgical Instruments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935367 | TAVA WIRE-DRIVER | HSZ | 1994-04-21 | 168 |
| K940109 | TAVA K-WIRE | HTY | 1994-02-22 | 43 |
| K885273 | MICRO SURGICAL INSTRUMENT SYSTEM | HSZ | 1989-01-30 | 39 |
| K884492 | MICRO SURGICAL INSTRUMENT SYSTEM | HSZ | 1988-11-16 | 21 |
| K872475 | SURGICAL BUR | GFF | 1987-07-02 | 9 |
| K863788 | SAWBLADE | GFA | 1986-10-14 | 18 |
| K854543 | PULSE LAVAGE | FQH | 1986-01-27 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Tava Surgical Instruments.
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 Tava Surgical Instruments?
FDA lists 7 510(k) clearances under the applicant name “Tava Surgical Instruments” (first 1986, latest 1994), across 5 product codes in 3 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 Tava Surgical Instruments?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tava Surgical Instruments is 39 days.
Which FDA product codes appear under Tava Surgical Instruments?
The most frequent FDA product codes under this applicant name are HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, 3); FQH (Lavage, Jet, 1); GFA (Blade, Saw, General & Plastic Surgery, Surgical, 1).
Next steps
- See all 7 Tava Surgical Instruments clearances with predicates and recalls
- Run predicate analysis for product code HSZ, Tava Surgical Instruments'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.