Forceps
FDA 510(k) K953962 · Biopsys Medical, Inc.
510(k) numberK953962
Submission
- Device name
- Forceps
- Applicant
- Biopsys Medical, Inc.
San Juan Capistrano, CA, US - Received
- August 22, 1995
- Decision date
- September 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K891401 | Hemostatic Forceps Bruns.,Gemini,Spencer-Well,KantGEN · Traditional | Zinnanti Surgical Instruments, Inc. | 04/06/1989SE |
More from Zinnanti Surgical Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970817 | Micromark ClipGDW · Traditional | 09/11/1997SE |
| K970565 | Mammotome Biopsy Probe and Housing (Mammotome)KNW · Traditional | 03/28/1997SE |
| K963015 | Surgical Staple Marker Device (Modify)GDW · Traditional | 10/07/1996SE |
| K960019 | Retractor Arm ClampFWZ · Traditional | 02/09/1996SE |
| K953880 | Biopsy NeedleKNW · Traditional | 09/08/1995SE |
| K951326 | Biopsy Device AccessoryBTA · Traditional | 05/15/1995SE |
| K951229 | Modified Biopsy NeedleKNW · Traditional | 04/06/1995SE |
| K950006 | Surgical Staple MarkerGDW · Traditional | 03/15/1995SE |
| K943863 | Needle GuideIYN · Traditional | 12/29/1994SE |
| K945573 | Biopsy Device AccessoryKNW · Traditional | 12/09/1994SE |
Questions and answers
When was Forceps cleared by the FDA?
Forceps (K953962) received a 510(k) decision of Substantially Equivalent on September 8, 1995, 17 days after the submission was received.
What is the product code of K953962?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.