Paralleling Guides
FDA 510(k) K914715 · Implant Corp. of America
510(k) numberK914715
Submission
- Device name
- Paralleling Guides
- Applicant
- Implant Corp. of America
St. Petersburg, FL, US - Received
- October 18, 1991
- Decision date
- February 16, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FZX – Guide, Surgical, Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871413 | Civco StepperFZX · Traditional | CIVCO Medical Instruments Co., Inc. | 07/14/1987SE |
| K871503 | Biopsy Needle Guide Kit, SterileFZX · Traditional | Amedic USA | 07/10/1987SE |
| K862564 | A.C.L. Guide KitFZX · Traditional | Aspen Laboratories, Inc. | 08/18/1986SE |
| K854262 | Meadox Surgimed Breast Localization Wire Set/OnlyFZX · Traditional | Meadox Surgimed, Inc. | 12/24/1985SE |
| K852402 | Namic Homer Mammalok Needle/Wire LocalizerFZX · Traditional | North American Instrument Corp. | 07/11/1985SE |
| K842698 | British Spinal Fusion SetFZX · Traditional | Downs Surgical , Ltd. | 09/12/1984SE |
| K841618 | Threading TubeFZX · Traditional | Plastafil, Inc. | 08/27/1984SE |
| K841619 | Drill GuideFZX · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K841297 | Techmedica Drill GuideFZX · Traditional | Techmedica, Inc. | 04/25/1984SE |
| K840835 | Straith Drain InserterFZX · Traditional | Surgical Technology Laboratories, Inc. | 04/23/1984SE |
More from Surgical Technology Laboratories, Inc.
Questions and answers
When was Paralleling Guides cleared by the FDA?
Paralleling Guides (K914715) received a 510(k) decision of Substantially Equivalent on February 16, 1994, 852 days after the submission was received.
What is the product code of K914715?
The FDA product code is FZX – Guide, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.