Surgical Stitch Cutter
FDA 510(k) K800103 · Macon & Co., Inc.
510(k) numberK800103
Submission
- Device name
- Surgical Stitch Cutter
- Applicant
- Macon & Co., Inc.
Mchenry, IL, US - Received
- January 16, 1980
- Decision date
- January 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZT – Cutter, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112400 | SmartshearsFZT · Traditional | Nuscience Consulting and Management Group, LLC | 09/12/2011SE |
| K890818 | Auto Suture Disposable Surgical Trocar*FZT · Traditional | United States Surgical, A Division of Tyco Healthc | 05/04/1989SE |
| K872990 | Micrins Surgical ScissorFZT · Traditional | Micrins Surgical, Inc. | 08/17/1987SE |
| K841741 | Single Hair Transplant GraftFZT · Traditional | Paris Products, Inc. | 07/23/1984SE |
| K841247 | SPC Disposable CutterFZT · Traditional | Surgical Products Corp. | 05/02/1984SE |
| K822448 | Scissors, VariousFZT · Traditional | J. Sklar Mfg. Co., Inc. | 09/14/1982SE |
| K821632 | Surgical Scissors, Set of 3FZT · Traditional | Fred Sammons, Inc. | 06/24/1982SE |
| K821361 | Conphar Tonsil ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821355 | Conphar Littauer ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821352 | Conphar Iris ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
More from Conphar, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K902802 | Fetal Monitoring Transducer StrapHGM · Traditional | 09/04/1990SE |
Questions and answers
When was Surgical Stitch Cutter cleared by the FDA?
Surgical Stitch Cutter (K800103) received a 510(k) decision of Substantially Equivalent on January 28, 1980, 12 days after the submission was received.
What is the product code of K800103?
The FDA product code is FZT – Cutter, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.