Skin Hooks, Various Types
FDA 510(k) K891898 · Zinnanti Surgical Instruments, Inc.
510(k) numberK891898
Submission
- Device name
- Skin Hooks, Various Types
- 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
- GDG – Hook, 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 GDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900069 | Modified PGL Absorbable Staple*GDG · Traditional | United States Surgical, A Division of Tyco Healthc | 04/16/1990SE |
| K864425 | Raylor(Tm) Dissecting HookGDG · Traditional | Cedar Surgical, Inc. | 12/12/1986SE |
| K843136 | Brimfield Cannulated Grasping HooksGDG · Traditional | Brimfield Scientific Instruments | 09/25/1984SE |
| K841010 | Surgical Hooks, VariousGDG · Traditional | Premier Dental Products Co. | 05/01/1984SE |
| K812562 | Surgical Retractor & Elastic Stays, DispGDG · Traditional | Humboldt Products | 10/02/1981SE |
| K791120 | Middle Ear Picks, Hooks Curettes,GDG · Traditional | Xomed, Inc. | 07/10/1979SE |
| K780289 | Nerve ApproximaterGDG · Traditional | Edward Weck, Inc. | 06/14/1978SE |
| K771190 | Abramson Trachea Hook & RetractorGDG · Traditional | Edward Weck, Inc. | 07/11/1977SE |
| K771187 | Dermahook #382-805GDG · Traditional | Edward Weck, Inc. | 07/11/1977SE |
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| 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 Skin Hooks, Various Types cleared by the FDA?
Skin Hooks, Various Types (K891898) 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 K891898?
The FDA product code is GDG – Hook, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.