Medisiss: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medisiss” (first 2003, latest 2011), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 120 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 |
|---|---|---|---|
| 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 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 Medisiss?
FDA lists 6 510(k) clearances under the applicant name “Medisiss” (first 2003, latest 2011), 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 Medisiss?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medisiss is 120 days.
Which FDA product codes appear under Medisiss?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); HRX (Arthroscope, 1); NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments, 1).
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. 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.