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FDA 510(k)

LAPAROSCOPIC BLADDER NECK SUSPENSION KIT

K-Number: K971797 · 1997-07-22

ApplicantLouisville Laboratories, Inc.
Decision Date1997-07-22
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC BLADDER NECK SUSPENSION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Louisville Laboratories, Inc.. It received FDA 510(k) clearance on 1997-07-22 under 510(k) number K971797. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPIC BLADDER NECK SUSPENSION KIT?

LAPAROSCOPIC BLADDER NECK SUSPENSION KIT is a medical device that received FDA 510(k) clearance on 1997-07-22. The listed applicant is Louisville Laboratories, Inc.. The 510(k) number is K971797.

When did LAPAROSCOPIC BLADDER NECK SUSPENSION KIT receive FDA 510(k) clearance?

LAPAROSCOPIC BLADDER NECK SUSPENSION KIT received FDA 510(k) clearance on 1997-07-22, under 510(k) number K971797.

Who is the listed applicant for LAPAROSCOPIC BLADDER NECK SUSPENSION KIT?

The FDA 510(k) record lists Louisville Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROSCOPIC BLADDER NECK SUSPENSION KIT?

The FDA product code for LAPAROSCOPIC BLADDER NECK SUSPENSION KIT is HET.

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Other records listing Louisville Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K980123CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SETK971796LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORSK971791VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSIONK971802VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSIONK971801LAPAROTOMY BLADDER NECK SUSPENSION KITK963076LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY

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Related Devices (Code: HET)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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