Bozeman Uterine Forceps, Straight, 10+410 0R 420
FDA 510(k) K852721 · The Huxley Instrument Corp.
510(k) numberK852721
Submission
- Device name
- Bozeman Uterine Forceps, Straight, 10+410 0R 420
- Applicant
- The Huxley Instrument Corp.
Penn Yan, NY, US - Received
- June 26, 1985
- Decision date
- September 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HCZ – Forceps, Surgical, Gynecological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HCZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172661 | Fetzer Medical Gynecological ForcepsHCZ · Traditional | Fetzer Medical GmbH & Co. KG | 05/08/2018SE |
| K134047 | Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand Gynecoloical…HCZ · Traditional | Integra LifeSciences Corporation | 04/11/2014SE |
| K092840 | Instrumed Forceps Obstetrical/GynaecologicalHCZ · Traditional | Instrumed International, Inc. | 12/03/2009SE |
| K944055 | Forceps, Surgical GynecologicalHCZ · Traditional | Owens Precision Systems, Inc. | 09/20/1994SE |
| K941528 | Pearl Packing ForcepsHCZ · Traditional | Cook Urological, Inc. | 05/12/1994SE |
| K926533 | Z-Clamp ForcepsHCZ · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K926531 | Hysterectomy ForcepsHCZ · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K926484 | Corson Myoma Grasping ForcepsHCZ · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K930799 | Various ForcepsHCZ · Traditional | Thomasville Medical Assoc. | 02/24/1994SE |
| K930039 | Forceps: Mcgravey, Mcindoe, GillisHCZ · Traditional | Thomasville Medical Assoc. | 02/24/1994SE |
More from Thomasville Medical Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K853016 | Stille Angular Rongeur, 8-3/4 SS 410 · Traditional | 08/07/1985SE |
| K852993 | Bone Rongeurs · Traditional | 08/07/1985SE |
| K853015 | Self-Centering Bone Holding Forceps, 10-1/4 SS420GEN · Traditional | 07/29/1985SE |
| K852716 | Taylor Percussion Hammer SS 410 or 420GWZ · Traditional | 07/26/1985SE |
| K852735 | Scalpel Handle #7 SS 410 or 420GDZ · Traditional | 07/15/1985SE |
| K852734 | O.R. Scissors, Straight, 5-1/2+SHP/SHP SS · Traditional | 07/15/1985SE |
| K852732 | Iris Scissors, Curved, 4-1/2+SS 410 or 420 · Traditional | 07/15/1985SE |
| K852731 | Lister Bandage Scissors, 5-1/2+SS 410 or 420 · Traditional | 07/15/1985SE |
| K852730 | Crile Forceps, Striaght, 6-1/4+SS 410 or 420GEN · Traditional | 07/15/1985SE |
| K852729 | Aalstead Mosq. Forceps, Straight, 5+SS 410 or 420HTD · Traditional | 07/15/1985SE |
Questions and answers
When was Bozeman Uterine Forceps, Straight, 10+410 0R 420 cleared by the FDA?
Bozeman Uterine Forceps, Straight, 10+410 0R 420 (K852721) received a 510(k) decision of Substantially Equivalent on September 6, 1985, 72 days after the submission was received.
What is the product code of K852721?
The FDA product code is HCZ – Forceps, Surgical, Gynecological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.