Prosurg, Inc.: FDA clearances and approvals
Prosurg, Inc. has 16 FDA 510(k) clearances (first 2000, latest 2016), across 12 product codes in 7 review panels. Median 510(k) review time: 142 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 182 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 3 | 262 |
| 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 |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 2 | 2 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| JEY | Plate, Bone | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GXR | Cover, Burr Hole | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 1 |
Plus 2 more product codes.
Review panels
- General and Plastic Surgery (5)
- Gastroenterology and Urology (4)
- Dental (2)
- Obstetrics and Gynecology (2)
- Ear, Nose and Throat (1)
- Neurology (1)
- Orthopedic (1)
Most recent Prosurg, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152511 | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula | HRX | 2016-07-11 | 313 |
| K152466 | Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) | EOQ | 2016-05-19 | 262 |
| K152619 | Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) | GCJ | 2016-04-29 | 228 |
| K120766 | ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) | FAJ | 2012-09-11 | 182 |
| K072528 | ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES | JEY | 2007-12-28 | 112 |
| K071138 | CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM | GXR | 2007-08-15 | 152 |
| K070737 | XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES | JEY | 2007-07-25 | 131 |
| K070846 | MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM | FTL | 2007-07-02 | 96 |
| K060326 | LASERTX - DIODE LASER & DELIVERY SYSTEM | GEX | 2006-04-05 | 55 |
| K050488 | TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES | FAS | 2005-04-01 | 35 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Prosurg, Inc..
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 Prosurg, Inc. have?
Prosurg, Inc. has 16 FDA 510(k) clearances (first 2000, latest 2016), across 12 product codes in 7 review panels.
How long does FDA take to clear Prosurg, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Prosurg, Inc.'s cleared 510(k)s is 142 days.
What devices does Prosurg, Inc. make?
Its most frequent FDA product codes are FAJ (Cystoscope And Accessories, Flexible/Rigid, 2); FTL (Mesh, Surgical, Polymeric, 2); GEX (Powered Laser Surgical Instrument, 2).
Has Prosurg, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Prosurg, Inc. Related entities may recall under other names.
Next steps
- See all 16 Prosurg, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FAJ, Prosurg, Inc.'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.