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FDA 510(k)

VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION

K-Number: K971802 · 1997-07-30

ApplicantLouisville Laboratories, Inc.
Decision Date1997-07-30
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION 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 1997-07-30 under 510(k) number K971802. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION?

VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION is a medical device that received FDA 510(k) clearance on 1997-07-30. The listed applicant is Louisville Laboratories, Inc.. The 510(k) number is K971802.

When did VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION receive FDA 510(k) clearance?

VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION received FDA 510(k) clearance on 1997-07-30, under 510(k) number K971802.

Who is the listed applicant for VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION?

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 VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION?

The FDA product code for VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION is MBI.

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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 SUSPENSIONK971801LAPAROTOMY BLADDER NECK SUSPENSION KITK971797LAPAROSCOPIC BLADDER NECK SUSPENSION KITK963076LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY

View all 12 devices →

Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

Official Source

View on FDA Database →

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

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