Multiple Manual Surgical Instruments
FDA 510(k) K832686 · Hirata Sangyo Co. USA, Inc.
510(k) numberK832686
Submission
- Device name
- Multiple Manual Surgical Instruments
- Applicant
- Hirata Sangyo Co. USA, Inc.
Mchenry, IL, US - Received
- August 2, 1983
- Decision date
- October 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTO – Reamer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HTO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111437 | Synthes Ria System (Expanded Indications)HTO · Traditional | Synthes (USA) Products, LLC | 08/10/2011SE |
| K042899 | Synthes (USA) Ria System - Expanded IndicationsHTO · Traditional | Synthes (Usa) | 03/16/2005SE |
| K013527 | Modification to Synthes (USA) Reamer Irrigator Aspirator (Ria) SystemHTO · Special | Synthes (Usa) | 12/21/2001SE |
| K993335 | Synthes Reamer/Irrigator/Aspirator (Ria) SystemHTO · Traditional | Synthes (Usa) | 06/12/2000SE |
| K954915 | Flexible Intramedullary ReamerHTO · Traditional | Zimmer, Inc. | 12/28/1995SE |
| K903248 | Combination ReamerHTO · Traditional | Onyx Medical Corp. | 07/30/1990SE |
| K885100 | Mcconnell Reamer GuideHTO · Traditional | Mcconnell Orthopedic | 01/13/1989SE |
| K870845 | Warsaw Orthopedic Pointed ReamerHTO · Traditional | Warsaw Orthopedic, Inc. | 03/11/1987SE |
| K862933 | ABC-1000 Small Joint ReamersHTO · Traditional | Instrumentation Industries, Inc. | 08/18/1986SE |
| K811081 | Medullary Canal ScrapersHTO · Traditional | The Anspach Effort, Inc. | 04/29/1981SE |
More from The Anspach Effort, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864106 | Sr-Model 230 (Modification)FRN · Traditional | 11/19/1986SE |
| K842289 | Sr- Model 230FRN · Traditional | 07/25/1984SE |
| K833542 | Surgical InstrumentGEN · Traditional | 11/28/1983SE |
| K833541 | Surgical InstrumentGAD · Traditional | 11/28/1983SE |
| K831583 | GP-303DXN · Traditional | 07/19/1983SE |
| K821989 | Non-Stetho 7, UM-15TPDXN · Traditional | 10/18/1982SE |
| K822571 | Syringe PumpFRN · Traditional | 10/08/1982SE |
Questions and answers
When was Multiple Manual Surgical Instruments cleared by the FDA?
Multiple Manual Surgical Instruments (K832686) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 73 days after the submission was received.
What is the product code of K832686?
The FDA product code is HTO – Reamer, a Class I (low risk) device regulated under 21 CFR 888.4540.