LAPAROTOMY BLADDER NECK SUSPENSION KIT— 510(k) K971801
Substantially EquivalentLouisville Laboratories, Inc.
FDA 510(k) clearance K971801 for LAPAROTOMY BLADDER NECK SUSPENSION KIT, Substantially Equivalent on 1997-07-22. Applicant: Louisville Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Louisville Laboratories, Inc.
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code EZL
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 EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
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.