Itimized Instruments
FDA 510(k) K790491 · E.M. Adams
510(k) numberK790491
Submission
- Device name
- Itimized Instruments
- Applicant
- E.M. Adams
Mchenry, IL, US - Received
- March 8, 1979
- Decision date
- April 4, 1979
- 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 |
|---|---|---|
| K971948 | Patient RestraintFMQ · Traditional | 08/06/1997SE |
| K971536 | Restraints (Vests and Jackets)FMQ · Traditional | 07/01/1997SE |
| K905173 | Splash GuardKYZ · Traditional | 04/25/1991SE |
| K910468 | Sterile Disposable Drape(S)FZI · Traditional | 03/21/1991SE |
| K873978 | Disposable Bipolar ForcepsGEN · Traditional | 11/23/1987SE |
| K850063 | Instrument Pocket · Traditional | 02/21/1985SE |
| K843724 | I.V. Start Kit & Obstetrical KitKKX · Traditional | 01/10/1985SE |
| K843783 | Wet PackEFQ · Traditional | 12/19/1984SE |
| K843782 | Dry TrayEFQ · Traditional | 12/13/1984SE |
| K843723 | Sterile Instrument Trays-VariousFSM · Traditional | 10/23/1984SE |
Questions and answers
When was Itimized Instruments cleared by the FDA?
Itimized Instruments (K790491) received a 510(k) decision of Substantially Equivalent on April 4, 1979, 27 days after the submission was received.
What is the product code of K790491?
The FDA product code is FZT – Cutter, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.