Louisville Laboratories, Inc.
Weston, MA, US
Louisville Laboratories, Inc. appears in FDA device records in Weston, MA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Louisville Laboratories, Inc. between 1989 and 1998. The busiest year on record is 1997, with 6. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 6 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K980123 | CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET | GCJ | Substantially Equivalent | |
| K971796 | LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS | EZL | Substantially Equivalent | |
| K971802 | VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION | MBI | Substantially Equivalent | |
| K971791 | VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION | MBI | Substantially Equivalent | |
| K971801 | LAPAROTOMY BLADDER NECK SUSPENSION KIT | EZL | Substantially Equivalent | |
| K971797 | LAPAROSCOPIC BLADDER NECK SUSPENSION KIT | HET | Substantially Equivalent | |
| K963076 | LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY | HET | Substantially Equivalent | |
| K960882 | CONTROL SYRINGE | FMF | Substantially Equivalent | |
| K955535 | LOUISVILLE LABS OXYGEN HEAD TENT | CBF | Substantially Equivalent | |
| K946282 | UNIVERSAL URETHRAL CATHETER | EZC | Substantially Equivalent | |
| K932979 | EXTERNAL STABILITY PAD | GCJ | Substantially Equivalent | |
| K894757 | T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE | BZT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain