Medisiss: FDA clearances and approvals
Medisiss has 6 FDA 510(k) clearances (first 2003, latest 2011), across 5 product codes in 3 review panels. Median 510(k) review time: 120 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 1 | 1 |
| NLR | Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed | 1 | 1 |
| NON | Forceps, Biopsy, Non-Electric, Reprocessed | 1 | 1 |
Review panels
Most recent Medisiss 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113028 | MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS | HRX | 2011-12-20 | 70 |
| K100543 | MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 | GEI | 2010-07-23 | 148 |
| K081559 | GENESIS | GEI | 2008-08-28 | 86 |
| K042659 | MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS | NON | 2005-02-14 | 139 |
| K030598 | MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS | NLQ | 2004-01-23 | 332 |
| K030919 | SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES | NLR | 2003-07-03 | 101 |
Recalls
openFDA lists no recalls under a recalling firm named Medisiss.
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 Medisiss have?
Medisiss has 6 FDA 510(k) clearances (first 2003, latest 2011), across 5 product codes in 3 review panels.
How long does FDA take to clear Medisiss's 510(k)s?
The median time from FDA receipt to decision across Medisiss's cleared 510(k)s is 120 days.
What devices does Medisiss make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); HRX (Arthroscope, 1); NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments, 1).
Has Medisiss had device recalls?
openFDA lists no recalls under a recalling firm name matching Medisiss. Related entities may recall under other names.
Next steps
- See all 6 Medisiss clearances with predicates and recalls
- Run predicate analysis for product code GEI, Medisiss'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.