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FDA 510(k)

ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002

K-Number: K982042 · 1998-09-08

ApplicantIsland Biosurgical, Inc.
Decision Date1998-09-08
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 is the device name listed in this FDA 510(k) record. The listed applicant is Island Biosurgical, Inc.. It received FDA 510(k) clearance on 1998-09-08 under 510(k) number K982042. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002?

ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 is a medical device that received FDA 510(k) clearance on 1998-09-08. The listed applicant is Island Biosurgical, Inc.. The 510(k) number is K982042.

When did ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 receive FDA 510(k) clearance?

ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 received FDA 510(k) clearance on 1998-09-08, under 510(k) number K982042.

Who is the listed applicant for ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002?

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

What is the FDA product code for ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002?

The FDA product code for ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 is OTN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Island Biosurgical, 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.

K973022ISLAND BIOSURGICAL INC. BNS KIT #1 & #2K960101ISLAND BIOSURGICAL BOLSTER

Related Devices (Code: OTN)

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.

K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP Suprapubic Sling SystemUrocure, LLCK222468ArcTO Transobturator Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK210087Athena Surgical RMUS SystemAthena Surgical, LLC

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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