Tissue Forceps
FDA 510(k) K822591 · Medcare Products
510(k) numberK822591
Submission
- Device name
- Tissue Forceps
- Applicant
- Medcare Products
Mchenry, IL, US - Received
- September 8, 1982
- Decision date
- October 13, 1982
- 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 |
|---|---|---|
| K841122 | Tracheostomy Care TrayFSM · Traditional | 04/25/1984SE |
| K841124 | Dialysis TrayKOC · Traditional | 04/20/1984SE |
| K841123 | Dressing Change TrayFRG · Traditional | 04/17/1984SE |
| K831374 | Med Care Prep Razor · Traditional | 10/04/1983SE |
| K831663 | Tissue ForcepsKOC · Traditional | 09/26/1983SE |
| K831665 | Disposable Needle HolderKDC · Traditional | 09/12/1983SE |
| K831664 | Plastic Thumb ForcepsKDC · Traditional | 09/12/1983SE |
| K831661 | Disposable ScissorsKDC · Traditional | 08/25/1983SE |
| K831662 | Disposable Hemostat (Straight&CurvedKDC · Traditional | 07/19/1983SE |
| K823854 | Medcare Suture Removal TraysFSM · Traditional | 03/31/1983SE |
Questions and answers
When was Tissue Forceps cleared by the FDA?
Tissue Forceps (K822591) received a 510(k) decision of Substantially Equivalent on October 13, 1982, 35 days after the submission was received.
What is the product code of K822591?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.