Product code HHW— Obstetrics/Gynecology
Always/Tampax bladder supports
- Classification name
- Pessary, Vaginal
- Device class
- Class 2
- Regulation
- 21 CFR 884.3575
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 41
- First cleared
- Most recent
Market context for product code HHW
FDA has cleared devices under product code HHW between 1977 and 2026, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2019
- 2018
- 2016
- 2015
- 2014
- 2013
- 2010
- 2009
- 2008
- 2006
- 2004
- 2003
Top applicants under product code HHW
Adverse events under product code HHW
product code HHW- Malfunction
- 485
- Total
- 485
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HHW
- K253698 — Milex Incontinence Dish Pessaries +3 more
- K250438 — CooperSurgical Milex® Pessaries
- K240798 — Cntrl+ Bladder Support Pessary
- K232677 — Reia pessary
- K232525 — Yoni.Fit Bladder Support
- K233548 — Uresta®
- K231786 — Gynethotics Pessary
- K190277 — ProVate Vaginal Support
- K183468 — Revive Reusable Bladder Support
- K173351 — Panpac Flexi Shelf Pessary
- K153422 — Panpac Disposable Pessary Fitting Set
- K151413 — Always/Tampax bladder supports
- K132313 — PESSARY
- K132670 — PANPAC INFLATABLE DOCUT PESSARY
- K131198 — TIPI OTC
- K092981 — PANPAC VAGINAL PESSARY
- K083769 — MODIFICATION TO URESTA PESSARY
- K081385 — URESTA PESSARY
- K060526 — TIPI
- K032644 — KOLPEXIN SPHERE
- K031463 — MARINA MEDICAL SILICONE PESSARY
- K020512 — MTI ST#1 SILICONE PESSARY
- K012277 — PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
- K013289 — BIOTEQUE VAGINAL PESSARIES
- K002329 — PELVX GELLHORN VAGINAL PESSARY 603-608
- K993308 — MENTOR EVACARE VAGINAL PESSARIES
- K990593 — PELVX INCONTINENCE DISH, MODEL 301-306
- K974115 — PELVX RING, PELVX RING WITH SUPPORT
- K974116 — PELVX INCONTINENCE RING
- K974117 — PELVX DONUT, PELVX CUBE
- K965040 — INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
- K930618 — VAGINAL CONTINENCE DEVICE
- K933654 — BLADDER NECK SUPPORT PROTHESIS FITTING KIT
- K920747 — PESSARY FLEXIBLE SILICONE DONUT RING
- K920187 — FLEXIBLE SILICONE GELIHORN
- K904774 — INGLAT-O-BALL
- K904026 — INFLAT-O-BALL
- K890565 — GELLHORN PESSARY 33410 VARIOUS SIZES
- K883721 — FEMALE CONTINENCE DEVICE
- K781863 — DEVICE, FEMALE INCONTINENCE
- K771548 — SILASTIC BRAND INTRAVAGINAL TARSETTE
Data sourced from openFDA. This site is unofficial and independent of the FDA.