LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY— 510(k) K963076
Substantially EquivalentLouisville Laboratories, Inc.
FDA 510(k) clearance K963076 for LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY, Substantially Equivalent on 1997-04-04. Applicant: Louisville Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Louisville Laboratories, Inc.
- 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
- Louisville, KY, US
Recent devices under product code HET
view allMore clearances from Louisville Laboratories, Inc.
view all- K980123 — CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
- K971796 — LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
- K971791 — VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
- K971802 — VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
- K971797 — LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
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.