Louisville Laboratories, Inc.: FDA clearances and approvals
Louisville Laboratories, Inc. has 12 FDA 510(k) clearances (first 1989, latest 1998), across 8 product codes in 6 review panels. Median 510(k) review time: 82 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 | 1 |
| CBF | Chamber, Hyperbaric | 1 | 1 |
| EZC | Catheter, Coude | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
Review panels
- Gastroenterology and Urology (3)
- Anesthesiology (2)
- Obstetrics and Gynecology (2)
- Orthopedic (2)
- General and Plastic Surgery (2)
- General Hospital (1)
Most recent Louisville Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980123 | CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET | GCJ | 1998-03-09 | 54 |
| K971796 | LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS | EZL | 1997-08-12 | 89 |
| K971802 | VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION | MBI | 1997-07-30 | 76 |
| K971791 | VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION | MBI | 1997-07-30 | 76 |
| K971801 | LAPAROTOMY BLADDER NECK SUSPENSION KIT | EZL | 1997-07-22 | 68 |
| K971797 | LAPAROSCOPIC BLADDER NECK SUSPENSION KIT | HET | 1997-07-22 | 68 |
| K963076 | LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY | HET | 1997-04-04 | 240 |
| K960882 | CONTROL SYRINGE | FMF | 1996-07-08 | 139 |
| K955535 | LOUISVILLE LABS OXYGEN HEAD TENT | CBF | 1996-07-01 | 209 |
| K946282 | UNIVERSAL URETHRAL CATHETER | EZC | 1995-03-31 | 94 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Louisville Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Louisville Laboratories, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Louisville Laboratories, Inc. have?
Louisville Laboratories, Inc. has 12 FDA 510(k) clearances (first 1989, latest 1998), across 8 product codes in 6 review panels.
How long does FDA take to clear Louisville Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Louisville Laboratories, Inc.'s cleared 510(k)s is 82 days.
What devices does Louisville Laboratories, Inc. make?
Its most frequent FDA product codes are EZL (Catheter, Retention Type, Balloon, 2); GCJ (Laparoscope, General & Plastic Surgery, 2); HET (Laparoscope, Gynecologic (And Accessories), 2).
Has Louisville Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Louisville Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 12 Louisville Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EZL, Louisville Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.