Elevators-Cottle,Mckenty,Goldman,Joseph,Converse
FDA 510(k) K891894 · Zinnanti Surgical Instruments, Inc.
510(k) numberK891894
Submission
- Device name
- Elevators-Cottle,Mckenty,Goldman,Joseph,Converse
- Applicant
- Zinnanti Surgical Instruments, Inc.
Chatsworth, CA, US - Received
- March 24, 1989
- Decision date
- April 12, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEG – Elevator, Surgical, 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 GEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891899 | Elevators, Various TypesGEG · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K890365 | Septum ElevatorGEG · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890253 | Surgical ElevatorGEG · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890230 | Ligature NeedlesGEG · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K872491 | 1.1 Twist Drills and 1.2 Cortical DrillsGEG · Traditional | Micro-Aire Surgical Instruments, Inc. | 07/16/1987SE |
| K870781 | Acromed Wallie-Heinig Disector/ElevatorsGEG · Traditional | Buckman Co., Inc. | 03/09/1987SE |
| K870591 | Elevator, Cobb SpinalGEG · Traditional | Military Engineering, Inc. | 02/26/1987SE |
| K870126 | Femur WrenchGEG · Traditional | Orthopedic Systems, Inc. | 02/03/1987SE |
| K864421 | Raylor(Tm) Periosteal ElevatorsGEG · Traditional | Cedar Surgical, Inc. | 11/26/1986SE |
| K834176 | H.R. Jakobi Surg. Instruments 40/41GEG · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
More from Imm Enterprises , Ltd.
| 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 Elevators-Cottle,Mckenty,Goldman,Joseph,Converse cleared by the FDA?
Elevators-Cottle,Mckenty,Goldman,Joseph,Converse (K891894) received a 510(k) decision of Substantially Equivalent on April 12, 1989, 19 days after the submission was received.
What is the product code of K891894?
The FDA product code is GEG – Elevator, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.