LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)— 510(k) K925079
Substantially EquivalentEndo Technic Corp.
FDA 510(k) clearance K925079 for LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER), Substantially Equivalent on 1994-08-24. Applicant: Endo Technic Corp.. Device class: 2.
Clearance details
- Applicant
- Endo Technic Corp.
- 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
- Northbrook, IL, US
Recent devices under product code HET
view allMore clearances from Endo Technic Corp.
view allAdverse 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 →
Recalls naming K925079
K-number listed on FDA's recall record- Z-2264-2013 — ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
- Z-2265-2013 — ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925079.
Data sourced from openFDA. This site is unofficial and independent of the FDA.