Ribbon Type Scissors: Tenotomy,Iris,Eye,Strabismus
FDA 510(k) K891200 · Zinnanti Surgical Instruments, Inc.
510(k) numberK891200
Submission
- Device name
- Ribbon Type Scissors: Tenotomy,Iris,Eye,Strabismus
- Applicant
- Zinnanti Surgical Instruments, Inc.
Chatsworth, CA, US - Received
- March 6, 1989
- Decision date
- April 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRW – Scissors, General, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LRW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911158 | Micro Scissors, 5MM Curve Micro Scissors, 5MMLRW · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K902828 | Suture Removal TrayLRW · Traditional | Orion Life Systems, Inc. | 08/08/1990SEKD |
| K900957 | GS-2100 Hook Suture Scissor, 5MMLRW · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900950 | GS-2000 Micro Scissor, Curved Left, 5MMLRW · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K892823 | Plaster Cutting ScissorsLRW · Traditional | The South India Surgical Co. Pvt. , Ltd. | 05/25/1989SE |
| K891889 | Olivecorona ScissorsLRW · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891886 | Scissors, Various TypesLRW · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891203 | Scissors: Thorek, Jorgensen, FinochiettoLRW · Traditional | Zinnanti Surgical Instruments, Inc. | 04/06/1989SE |
| K890235 | Dressing ScissorsLRW · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890170 | ScissorsLRW · Traditional | Dhason Brothers, Inc. | 02/03/1989SE |
More from Dhason Brothers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925501 | Nylon Coated SpeculaHIB · Traditional | 06/13/1997SE |
| K941458 | Uterine Manipulator/Injector with SpringLKF · Traditional | 01/25/1995SE |
| K941457 | Uterine Injector with SpringLKF · Traditional | 01/24/1995SE |
| K925560 | Zsi Loop, Zsi Ball & Zsi Needle ElectrodesHGI · Traditional | 08/30/1994SE |
| K925960 | Forceps for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K925957 | Scissors for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K926021 | Needle Holders & Access for Lapar Surg-Ob/Gyn UseHET · Traditional | 04/07/1994SE |
| K925958 | Scissor for Laparoscopic Surgery Gu UseGCJ · Traditional | 03/24/1994SE |
| K926181 | Zsi Laparoscopes-General & Plastic SurgeryGCJ · Traditional | 12/17/1993SE |
| K926016 | Needle Holders & Access for Lapar Surg-Gu UseGCJ · Traditional | 11/12/1993SE |
Questions and answers
When was Ribbon Type Scissors: Tenotomy,Iris,Eye,Strabismus cleared by the FDA?
Ribbon Type Scissors: Tenotomy,Iris,Eye,Strabismus (K891200) received a 510(k) decision of Substantially Equivalent on April 6, 1989, 31 days after the submission was received.
What is the product code of K891200?
The FDA product code is LRW – Scissors, General, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.