Monik - Disposable Endoscopic Trocar— 510(k) K233386
Substantially EquivalentM/s. Meril Endo Surgery Private Limited.
FDA 510(k) clearance K233386 for Monik - Disposable Endoscopic Trocar, Substantially Equivalent on 2024-05-24. Applicant: M/s. Meril Endo Surgery Private Limited.. Device class: 2.
Clearance details
- Applicant
- M/s. Meril Endo Surgery Private Limited.
- Product code
- Product 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
- Vapi, IN
Recent devices under product code GCJ
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- K232246 — 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture +1 more
- K230981 — Meriglu Topical Skin Adhesive
- K200452 — Meril-Bonewax
- K200320 — Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
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.