KOLPLAST Collin
KOLPLAST Collin is a Class II device made by Kolplast CI SA, cleared under FDA 510(k) K973853 on 19 Dec 1997 and listed in FDA GUDID since 13 Sep 2019 (UDI-DI 07898027903519), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07898027903519 | Date13 Sep 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK973853 | Date19 Dec 1997 | StatusActive |
Official records
- AccessGUDID record 07898027903519
- FDA 510(k) database K973853
Across registries
- FDA 510(k) K973853 decided 19 Dec 1997 Active
- FDA GUDID UDI-DI 07898027903519 listed 13 Sep 2019 Listed
Timeline
- Cleared FDA 510(k) K973853
- Listed FDA GUDID 07898027903519
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kolplast
- Generic name
- Vaginal speculum, single-use
- Model / reference
- Collin
- Primary DI / UDI-DI
- 07898027903519
- 510(k) Number
- FDA product code
- HIB
- GMDN term
- Vaginal speculum, single-use
- Device class
- Class II
- Regulation number
- 884.4530
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HIB (Speculum, Vaginal, Nonmetal).
- SPECULUM, VAGINAL, NONMETAL by Welch Allyn, Inc.
- PHYSICIAN'S CHOICE by Advance Medical Device, Inc.
- PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS by Playtex Products, Inc.
- INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION by Olsen Electrosurgical, Inc.
- DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE by Dukal LLC
- PRO-SPEC by Exitec, Inc.
- PATTON SPECULUM by Patton Medical Corp.
- VITALCARE DISPOSABLE VAGINAL SPECULUM by Vitalcare Group, Inc.
- DIA-SPEC by Exitec, Inc.
- HIERSPEC SPECULUM by Medical Products Div.