Centurion Vaginal Speculum
FDA 510(k) K897100 · Tri-State Hospital Supply Corp.
510(k) numberK897100
Submission
- Device name
- Centurion Vaginal Speculum
- Applicant
- Tri-State Hospital Supply Corp.
Howell, MI, US - Received
- December 21, 1989
- Decision date
- March 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIC – Speculum, Vaginal, Nonmetal, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955790 | Pap Plus Speculoscopy Comprehensive Pelvic Exam TrayHIC · Traditional | Trylon Corp. | 03/21/1996SE |
| K923656 | Lighting Source SystemHIC · Traditional | Galenica Enterprises, Inc. | 09/08/1994SE |
| K902516 | New Length Sugita AppliersHIC · Traditional | Sims Surgical, Inc. | 07/03/1990SE |
| K853257 | Speculite Disposable Vaginal LightHIC · Traditional | Trylon Associates, Ltd. | 12/27/1985SE |
More from Trylon Associates, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K080448 | Centurion Protective Restraint, SCR SeriesFMQ · Traditional | 08/28/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | 04/23/2008SE |
| K942353 | Centurion Umbilical CatheterFOS · Traditional | 08/15/1995SE |
| K945977 | Centurion(R) Site Guard(R) Transparent Dressing/Transpaent Film DressingMGP · Traditional | 03/29/1995SE |
| K931748 | Centlurion Disp Steri Dental/Hygiene Pack/TraysLJT · Traditional | 02/25/1994SESK |
| K935491 | Centurion Mogen Clamp/Circumcision (Ster/Non Ster)HFX · Traditional | 02/17/1994SE |
| K923812 | Centurion Disposable InstrumentsMDM · Traditional | 12/17/1992SE |
| K910906 | Centurion Kleen-Needle System I.V. Extension SetsFPK · Traditional | 04/01/1991SE |
| K896320 | Centurion Kleen-Needle SystemFMI · Traditional | 01/11/1990SE |
| K893647 | Copolyester Film DressingKGN · Traditional | 10/16/1989SE |
Questions and answers
When was Centurion Vaginal Speculum cleared by the FDA?
Centurion Vaginal Speculum (K897100) received a 510(k) decision of Substantially Equivalent on March 16, 1990, 85 days after the submission was received.
What is the product code of K897100?
The FDA product code is HIC – Speculum, Vaginal, Nonmetal, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 884.4530.