Surgical Instrument
FDA 510(k) K833541 · Hirata Sangyo Co. USA, Inc.
510(k) numberK833541
Submission
- Device name
- Surgical Instrument
- Applicant
- Hirata Sangyo Co. USA, Inc.
Mchenry, IL, US - Received
- September 27, 1983
- Decision date
- November 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAD – Retractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152538 | JRP Wound SpreaderGAD · Traditional | J.R. Parker, LLC | 04/13/2016SE |
| K151104 | Otelo LLGAD · Traditional | Spineart | 01/06/2016SE |
| K132645 | Thoratrak Mics Retractor System, Rack, BladesGAD · Traditional | Medtronic, Inc. | 10/04/2013SE |
| K071775 | DashGAD · Traditional | Ezsurgical | 08/07/2007SE |
| K050256 | Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional | Apple Medical Corp. | 04/26/2005SE |
| K043602 | Quadrant Retractor SystemGAD · Traditional | Medtronic Sofamor Danek | 02/23/2005SE |
| K001339 | MRI Fastsystem Retractor SystemGAD · Special | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 05/17/2000SE |
| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional | Clarus Medical Systems, Inc. | 08/18/1998SE |
| K963006 | Scion Saphenous Vein Harvesting SystemGAD · Traditional | Scion International, Inc. | 09/20/1996SE |
| K943875 | Villalta RetractorGAD · Traditional | Hct, Inc. | 11/09/1994SE |
More from Hct, 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 |
| K832686 | Multiple Manual Surgical InstrumentsHTO · Traditional | 10/14/1983SE |
| 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 Surgical Instrument cleared by the FDA?
Surgical Instrument (K833541) received a 510(k) decision of Substantially Equivalent on November 28, 1983, 62 days after the submission was received.
What is the product code of K833541?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.