Thorocoscopy Self-Retaining Retractor
FDA 510(k) K926585 · T. Korossurgical Instruments Corp.
510(k) numberK926585
Submission
- Device name
- Thorocoscopy Self-Retaining Retractor
- Applicant
- T. Korossurgical Instruments Corp.
Moorepark, CA, US - Received
- September 18, 1992
- Decision date
- August 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAD – Retractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| 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 |
|---|---|---|
| K001915 | Graft Marker RingMAB · Traditional | 04/27/2001SE |
| K002755 | Non-Absorbing Sternatomy Monofilament SutureLRN · Traditional | 12/04/2000SE |
| K954016 | Videoscope W/Irrigation SheathHRX · Traditional | 01/25/1996SN |
| K953998 | Discetome Tissue AspiratorHRX · Traditional | 12/04/1995SE |
| K954052 | Arthroscopic Grasper, Cup Forceps and CurettesHRX · Traditional | 11/06/1995SN |
| K954014 | Percutaneous Discectomy Cannula SystemHRX · Traditional | 11/06/1995SN |
| K935529 | Cervical Self-Retaining RetractorGZT · Traditional | 03/22/1994SE |
| K931262 | Reusable/Interchangeable Shaft, Endoscopic ScissorGCJ · Traditional | 08/06/1993SE |
| K926583 | Reusable Endoscopic Scissors, Grasper-MonopolarGCJ · Traditional | 08/06/1993SE |
| K931259 | Endoscopic or Thorascopic ForcepsGCJ · Traditional | 06/08/1993SE |
Questions and answers
When was Thorocoscopy Self-Retaining Retractor cleared by the FDA?
Thorocoscopy Self-Retaining Retractor (K926585) received a 510(k) decision of Substantially Equivalent on August 6, 1993, 322 days after the submission was received.
What is the product code of K926585?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.