C Ring Clincher
FDA 510(k) K781446 · Orthopedic Equipment Co., Inc.
510(k) numberK781446
Submission
- Device name
- C Ring Clincher
- Applicant
- Orthopedic Equipment Co., Inc.
Mchenry, IL, US - Received
- August 23, 1978
- Decision date
- September 27, 1978
- 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 |
|---|---|---|
| K834035 | Universal Self-Aligning Acetabular ComJDI · Traditional | 06/19/1984SE |
| K841189 | Oec/Rezaian Spinal FixatorKWQ · Traditional | 05/16/1984SE |
| K800530 | Schlein Tri-Surface AnkleHSN · Traditional | 04/02/1980SE |
| K781445 | SpreaderGAD · Traditional | 09/27/1979SE |
| K790247 | Tourniquet Test Gage · Traditional | 02/26/1979SE |
| K790209 | Filter System, Altner DisposableGAZ · Traditional | 02/26/1979SE |
| K781451 | Flat WrenchHXS · Traditional | 09/27/1978SE |
| K781450 | DriversGFC · Traditional | 09/27/1978SE |
| K781449 | Harrington Spinal ElevatorGEG · Traditional | 09/27/1978SE |
| K781448 | Harrington Hook ClampGEN · Traditional | 09/27/1978SE |
Questions and answers
When was C Ring Clincher cleared by the FDA?
C Ring Clincher (K781446) received a 510(k) decision of Substantially Equivalent on September 27, 1978, 35 days after the submission was received.
What is the product code of K781446?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.