Forcep
FDA 510(k) K812205 · Reznik Instruments
510(k) numberK812205
Submission
- Device name
- Forcep
- Applicant
- Reznik Instruments
Mchenry, IL, US - Received
- August 4, 1981
- Decision date
- October 26, 1981
- 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 |
|---|---|---|
| K812201 | Photographic EquipmentFEM · Traditional | 10/19/1981SE |
| K812206 | LaparoscopeHET · Traditional | 10/13/1981SE |
| K812204 | Uterine ManipulatorsKOH · Traditional | 10/13/1981SE |
| K812203 | Electrosurgical UnitGEI · Traditional | 10/13/1981SE |
| K812199 | Trocar & Trocar SleevesHET · Traditional | 10/13/1981SE |
| K812202 | Fiber Optic Light SourceHIH · Traditional | 09/29/1981SE |
| K812200 | InsufflatorHIF · Traditional | 09/29/1981SE |
| K812198 | Accessories(Probes, Suction Tubes, Etc.)GEI · Traditional | 09/11/1981SE |
Questions and answers
When was Forcep cleared by the FDA?
Forcep (K812205) received a 510(k) decision of Substantially Equivalent on October 26, 1981, 83 days after the submission was received.
What is the product code of K812205?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.