Straith Chisel Forceps
FDA 510(k) K801075 · Surgical Technology Laboratories, Inc.
510(k) numberK801075
Submission
- Device name
- Straith Chisel Forceps
- Applicant
- Surgical Technology Laboratories, Inc.
Mchenry, IL, US - Received
- May 6, 1980
- Decision date
- May 20, 1980
- 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 |
|---|---|---|
| K170582 | Saf-T-Vac Smoke and Fluid EvacuatorGEI · Traditional | 04/14/2017SE |
| K021889 | Surgiform Augmentation Material (S.F.A.M.)KKY · Traditional | 10/16/2002SE |
| K983756 | Surgiform Anatomical MalarLZK · Special | 11/20/1998SE |
| K983755 | Nasal Dorsal SeriesFZE · Special | 11/20/1998SE |
| K983754 | Standard ChinFWP · Special | 11/20/1998SE |
| K964443 | Surgiform Anatomical MalarLZK · Traditional | 12/20/1996SE |
| K840835 | Straith Drain InserterFZX · Traditional | 04/23/1984SE |
| K831078 | Straith Oral AirwayCAE · Traditional | 06/24/1983SE |
| K801074 | Straith Nasal ImplantFZE · Traditional | 06/17/1980SE |
| K801072 | Straith Nasal SplintFYI · Traditional | 06/17/1980SE |
Questions and answers
When was Straith Chisel Forceps cleared by the FDA?
Straith Chisel Forceps (K801075) received a 510(k) decision of Substantially Equivalent on May 20, 1980, 14 days after the submission was received.
What is the product code of K801075?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.