510(k) Report

FDA applicant

Louisville Laboratories, Inc.

Louisville, KY12 decisions1989–19981 recall

FDA records 12 decisions for Louisville Laboratories, Inc. (Louisville, KY) from 1989 to 1998: 12 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 11 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Louisville Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Louisville Laboratories, Inc. since 2007.

Recalls per year

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Louisville Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Louisville Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HETLaparoscope, Gynecologic (And Accessories)2decisions
  • GCJLaparoscope, General & Plastic Surgery2decisions
  • EZLCatheter, Retention Type, Balloon2decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue2decisions
  • CBFChamber, Hyperbaric1decision
  • FMFSyringe, Piston1decision

Also: BZT (1), EZC (1).

Whose devices does it build on?

Its devices cite 11 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K963076Laparoscopic Bone Anchored Urethropexy Instrument TrayLouisville Laboratories, Inc. · 19976cite it
  • K980123Carter-Thomason Needle-Point Suture Passer Instrument SetLouisville Laboratories, Inc. · 19986cite it
  • K971797Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc. · 19972cite it
  • K971801Laparotomy Bladder Neck Suspension KitLouisville Laboratories, Inc. · 19971cites it
  • K971802Vaginal Suturing Kit for Bladder Neck SuspensionLouisville Laboratories, Inc. · 19971cites it
  • K971791Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionLouisville Laboratories, Inc. · 19971cites it

What has FDA decided for it lately?

  • K980123Carter-Thomason Needle-Point Suture Passer Instrument SetLouisville Laboratories, Inc. · 19981 recall
  • K971796Laparotomy Bladder Neck Suspension Kit with Bone AnchorsLouisville Laboratories, Inc. · 1997
  • K971802Vaginal Suturing Kit for Bladder Neck SuspensionLouisville Laboratories, Inc. · 1997
  • K971791Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionLouisville Laboratories, Inc. · 1997
  • K971797Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997
  • K971801Laparotomy Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997
  • K963076Laparoscopic Bone Anchored Urethropexy Instrument TrayLouisville Laboratories, Inc. · 1997
  • K960882Control SyringeLouisville Laboratories, Inc. · 1996

All 12 as Louisville Laboratories, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K980123Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box…Aug 29, 2023Class II

Other applicant names beginning “Louisville”

FDA records each applicant name separately; these may or may not be the same firm.

Louisville Apl Diagnostics, Inc. 3