510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971797Substantially Equivalent

Laparoscopic Bladder Neck Suspension Kit

Louisville Laboratories, Inc., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971797 is the FDA 510(k) clearance record for LAPAROSCOPIC BLADDER NECK SUSPENSION KIT, a class II device, cleared for Louisville Laboratories, Inc. on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 12 510(k) clearances for Louisville Laboratories, Inc., from to . As of , FDA records show no recalls naming K971797.

Clearance record

Decision date
Received
(68 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Louisville Laboratories, Inc. 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code HET

Trailing 12 months

FDA records hold no clearances under product code HET in the trailing twelve months.

FDA records show no clearances under product code HET in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HET, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260