Vance-Ambrose Resectoscope Forceps
FDA 510(k) K812785 · Vance Products, Inc.
510(k) numberK812785
Submission
- Device name
- Vance-Ambrose Resectoscope Forceps
- Applicant
- Vance Products, Inc.
Mchenry, IL, US - Received
- October 5, 1981
- Decision date
- November 16, 1981
- 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 |
|---|---|---|
| K820313 | Vpi-Fair Urethral StentKOD · Traditional | 03/01/1982SE |
| K812995 | Vance-Jacobellis Microhematuria CatheterKOD · Traditional | 03/01/1982SE |
| K813278 | Vpi Ureteral Dilatation Ballon CatheterEZN · Traditional | 12/18/1981SE |
| K812057 | Vance CystoscopicFBK · Traditional | 07/31/1981SE |
| K811833 | Vnace Fascial Dilator SetKOE · Traditional | 07/10/1981SE |
| K811454 | Vance Prostatic Aspiration SetKNW · Traditional | 06/09/1981SE |
| K810372 | Vance Deflectable Biopsy Brush SetKOD · Traditional | 03/20/1981SE |
| K810371 | Vance Urethal Dilator SetKOE · Traditional | 03/20/1981SE |
| K810370 | Pollack Chain Cysourethrogram SetFGI · Traditional | 03/20/1981SE |
| K810368 | Vance Percutaneous Malecot NephrostomyKOB · Traditional | 03/20/1981SE |
Questions and answers
When was Vance-Ambrose Resectoscope Forceps cleared by the FDA?
Vance-Ambrose Resectoscope Forceps (K812785) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 42 days after the submission was received.
What is the product code of K812785?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.