Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula— 510(k) K152511
Substantially EquivalentProsurg, Inc.
FDA 510(k) clearance K152511 for Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula, Substantially Equivalent on 2016-07-11. Applicant: Prosurg, Inc.. Device class: 2.
Clearance details
- Applicant
- Prosurg, Inc.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code HRX
view allMore clearances from Prosurg, Inc.
view all- K152466 — Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
- K152619 — Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
- K120766 — ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
- K072528 — ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
- K071138 — CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.