Self-Centering Bone Holding Forceps, 10-1/4 SS420
FDA 510(k) K853015 · The Huxley Instrument Corp.
510(k) numberK853015
Submission
- Device name
- Self-Centering Bone Holding Forceps, 10-1/4 SS420
- Applicant
- The Huxley Instrument Corp.
Penn Yan, NY, US - Received
- July 17, 1985
- Decision date
- July 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEN – Forceps, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031828 | Naturalase LP Nd:Yag LaserGEN · Traditional | Focus Medical, LLC | 07/17/2003SE |
| K953962 | ForcepsGEN · Traditional | Biopsys Medical, Inc. | 09/08/1995SE |
| K932385 | Suture Removing ForcepsGEN · Traditional | Rocket of London, Ltd. | 08/06/1993SE |
| K904723 | ForcepsGEN · Traditional | Minto Research & Development, Inc. | 07/26/1991SE |
| K911159 | Palpation ProbeGEN · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K900960 | GS-1500 Claw Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900952 | GS-1200 Grasping/Extracting Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900951 | GS-7000 Clip-Applying Forcep, 10MM, Medium ClipGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900948 | GS-1002 Grasping Forcep, 5MM with RatchetGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K891896 | Tissue Forceps, Various TypesGEN · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
More from Zinnanti Surgical Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K852721 | Bozeman Uterine Forceps, Straight, 10+410 0R 420HCZ · Traditional | 09/06/1985SE |
| K853016 | Stille Angular Rongeur, 8-3/4 SS 410 · Traditional | 08/07/1985SE |
| K852993 | Bone Rongeurs · Traditional | 08/07/1985SE |
| 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 Self-Centering Bone Holding Forceps, 10-1/4 SS420 cleared by the FDA?
Self-Centering Bone Holding Forceps, 10-1/4 SS420 (K853015) received a 510(k) decision of Substantially Equivalent on July 29, 1985, 12 days after the submission was received.
What is the product code of K853015?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.