Forceps, Haemostatic, 14 16,&18 Cm. Long
FDA 510(k) K770538 · Sea-Pac Trading Corp.
510(k) numberK770538
Submission
- Device name
- Forceps, Haemostatic, 14 16,&18 Cm. Long
- Applicant
- Sea-Pac Trading Corp.
Mchenry, IL, US - Received
- March 21, 1977
- Decision date
- April 15, 1977
- 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 |
|---|---|---|
| K770544 | Scissors, Bandage, 15,18,20CM., AngularFZT · Traditional | 04/15/1977SE |
| K770543 | Scissors, Surgical, Angular, 14 Cm.FZT · Traditional | 04/15/1977SE |
| K770542 | Scissors, Mayo _Tyle, 14,16,18,20,22 Cm.FZT · Traditional | 04/15/1977SE |
| K770541 | Scissors, Surgical, 12.5,14,16 & 18 Cm.FZT · Traditional | 04/15/1977SE |
| K770540 | Forceps, Mosquito Style, 12.5 Cm.GEN · Traditional | 04/15/1977SE |
| K770539 | Forceps, Haem, Deep Operation, 20&22 Cm.GEN · Traditional | 04/15/1977SE |
Questions and answers
When was Forceps, Haemostatic, 14 16,&18 Cm. Long cleared by the FDA?
Forceps, Haemostatic, 14 16,&18 Cm. Long (K770538) received a 510(k) decision of Substantially Equivalent on April 15, 1977, 25 days after the submission was received.
What is the product code of K770538?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.