Suture Removal Kit
FDA 510(k) K810685 · Medical Action Industries, Inc.
510(k) numberK810685
Submission
- Device name
- Suture Removal Kit
- Applicant
- Medical Action Industries, Inc.
Mchenry, IL, US - Received
- March 13, 1981
- Decision date
- March 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 |
|---|---|---|
| K042526 | Drape, Surgical, X-Ray Element, Models Non Sterile 6120-00, Sterile 704-B, Non Sterile…KKX · Traditional | 04/25/2005SE |
| K042527 | Spatula, Cervical, Cytological, Model 22-9107HHT · Traditional | 11/08/2004SE |
| K022948 | Vaginal Speculum, Model 5555S, 5555M, or 5555LHIB · Traditional | 11/04/2002SE |
| K946019 | Surgicla Instrument KitFRG · Traditional | 03/20/1995SE |
| K923846 | Burn DressingNAB · Traditional | 09/11/1992SE |
| K884826 | Gauze SpongeEFQ · Traditional | 12/22/1988SE |
| K810184 | Laparotomy SpongeGDY · Traditional | 02/04/1981SE |
Questions and answers
When was Suture Removal Kit cleared by the FDA?
Suture Removal Kit (K810685) received a 510(k) decision of Substantially Equivalent on March 26, 1981, 13 days after the submission was received.
What is the product code of K810685?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.