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Island Biosurgical Bladder Neck Bolstr Model IBIBOL.002

by Island Biosurgical, Inc.

510(k) K982042

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982042 Date8 Sep 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OTN
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Island Biosurgical Bladder Neck Bolstr Model IBIBOL.002 is a surgical mesh device classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator. It is intended for use in the surgical correction of female stress urinary incontinence due to pelvic relaxation.

The device is supplied by Island Biosurgical, Inc. and was cleared via the FDA 510(k) pathway under K982042 with a decision date of September 8, 1998. It is classified as a Class II medical device under regulation number 878.3300 and product code OTN, with a review panel designation of Gastroenterology/Urology (GU).

Other devices from Island Biosurgical, Inc.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Island Biosurgical Bladder Neck Bolstr Model IBIBOL.002 used for?

    It is intended for use in the surgical correction of female stress urinary incontinence due to pelvic relaxation, as a synthetic urogynecologic mesh device implanted via retropubic or transobturator approach.

  • How is the Island Biosurgical Bladder Neck Bolstr Model IBIBOL.002 supplied and is it sterile?

    The device is supplied by Island Biosurgical, Inc., but the provided data does not specify sterility status, single-use or reusable designation, or packaging details; therefore, sterility and supply format cannot be confirmed from the given information.

  • What regulatory pathway cleared the Island Biosurgical Bladder Neck Bolstr Model IBIBOL.002 and when?

    It was cleared via the FDA 510(k) traditional pathway under submission K982042, with a decision date of September 8, 1998, and found substantially equivalent to a predicate device.