PRIMUS INSULATED FORCEPS— 510(k) K932832
Substantially EquivalentMarlo Surgical Technology
FDA 510(k) clearance K932832 for PRIMUS INSULATED FORCEPS, Substantially Equivalent on 1994-02-25. Applicant: Marlo Surgical Technology. Device class: 2.
Clearance details
- Applicant
- Marlo Surgical Technology
- Product code
- Code HET
- Device class
- Class 2
- Regulation
- 21 CFR 884.1720
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Willoughby, OH, US
Recent devices under product code HET
view allMore clearances from Marlo Surgical Technology
view all- K960810 — BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
- K962273 — MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
- K924611 — IRRIGATION PUMP AND TUBING SET
- K932634 — NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES
- K920611 — MARLOW LAPAROSCOPIC GRASPING FORCEP
Adverse events under product code HET
product code HET- Malfunction
- 10,504
- Total
- 10,504
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.