LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR— 510(k) K912023
Substantially EquivalentLaserscope
FDA 510(k) clearance K912023 for LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR, Substantially Equivalent on 1991-06-11. Applicant: Laserscope. Device class: 2.
Clearance details
- Applicant
- Laserscope
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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More clearances from Laserscope
view all- K062719 — GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
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- K034011 — GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
- K024206 — AURA ISURGICAL LASER SYSTEM & ACCESSORIES
- K020021 — LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.