SURGICAL CUTTER— 510(k) K955168
Substantially EquivalentPromex, Inc.
FDA 510(k) clearance K955168 for SURGICAL CUTTER, Substantially Equivalent on 1996-01-22. Applicant: Promex, Inc.. Device class: 2.
Clearance details
- Applicant
- Promex, 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
- Indianapolis, IN, US
Recent devices under product code GEI
view allMore clearances from Promex, 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 K955168
K-number listed on FDA's recall record- Z-2767-2015 — NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
- Z-2045-2016 — Myriad handpiece Tissue morcellator
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955168.
Data sourced from openFDA. This site is unofficial and independent of the FDA.