RE-NEW LAPAROSCOPIC INSTRUMENTS— 510(k) K962119
Substantially EquivalentMicroline Pentax, Inc.
FDA 510(k) clearance K962119 for RE-NEW LAPAROSCOPIC INSTRUMENTS, Substantially Equivalent on 1996-08-09. Applicant: Microline Pentax, Inc.. Device class: 2.
Clearance details
- Applicant
- Microline Pentax, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
Recent devices under product code GEI
view allMore clearances from Microline Pentax, Inc.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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 →
Recalls naming K962119
K-number listed on FDA's recall record- Z-1741-2018 — ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
- Z-0507-2018 — The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962119.
Data sourced from openFDA. This site is unofficial and independent of the FDA.