Cleared Traditional

K965040 - INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL

K965040 is an FDA 510(k) clearance for INTROL BLADDER NECK SUPPORT PROSTHESIS ..., manufactured by Johnson & Johnson Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K965040 · Johnson & Johnson Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
83d
Days
Class 2
Risk

K965040 is an FDA 510(k) clearance for the INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on March 10, 1997 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3575 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Johnson & Johnson Medical, Inc. devices

FDA 510(k) Submission Details - K965040

510(k) Number K965040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1996
Decision Date March 10, 1997
Days to Decision 83 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 160d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHW Device Classification - Class 2, Special Controls

Product Code HHW Pessary, Vaginal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3575
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHW Pessary, Vaginal

All 24
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K965040.
PELVX RING, PELVX RING WITH SUPPORT
K974115 · Deschutes Medical Products, Inc. · Apr 1998
PELVX INCONTINENCE RING
K974116 · Deschutes Medical Products, Inc. · Apr 1998
PELVX DONUT, PELVX CUBE
K974117 · Deschutes Medical Products, Inc. · Apr 1998
VAGINAL CONTINENCE DEVICE
K930618 · Johnson & Johnson Medical, Inc. · May 1995
BLADDER NECK SUPPORT PROTHESIS FITTING KIT
K933654 · Johnson & Johnson Medical, Inc. · May 1995
FEMALE CONTINENCE DEVICE
K883721 · Cook Ob/Gyn · Oct 1988