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FDA 510(k)

INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL

K-Number: K965040 · 1997-03-10

ApplicantJohnson & Johnson Medical, Inc.
Decision Date1997-03-10
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1997-03-10 under 510(k) number K965040. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL?

INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL is a medical device that received FDA 510(k) clearance on 1997-03-10. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K965040.

When did INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL receive FDA 510(k) clearance?

INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL received FDA 510(k) clearance on 1997-03-10, under 510(k) number K965040.

Who is the listed applicant for INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL?

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

What is the FDA product code for INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL?

The FDA product code for INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL is HHW.

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Other records listing Johnson & Johnson Medical, Inc. as applicant

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Related Devices (Code: HHW)

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.

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper SurgicalK250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.

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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