GAD — Retractor Class I
FDA product code GAD covers "Retractor", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAD
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K152538 | j.r. parker | JRP Wound Spreader | April 13, 2016 |
| K151104 | spineart | OTELO LL | January 6, 2016 |
| K132645 | medtronic | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | October 4, 2013 |
| K071775 | ezsurgical | DASH | August 7, 2007 |
| K050256 | apple medical | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | April 26, 2005 |
| K043602 | medtronic sofamor danek | QUADRANT RETRACTOR SYSTEM | February 23, 2005 |
| K001339 | omni-tract surgical, div. minn. scientific | MRI FASTSYSTEM RETRACTOR SYSTEM | May 17, 2000 |
| K980588 | clarus medical systems | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | August 18, 1998 |
| K963006 | scion international | SCION SAPHENOUS VEIN HARVESTING SYSTEM | September 20, 1996 |
| K943875 | hct | VILLALTA RETRACTOR | November 9, 1994 |
| K942002 | automated medical products | RETRACTOR | May 17, 1994 |
| K941448 | technovations | RETRACTOR | April 15, 1994 |
| K930316 | thomasville medical assoc | LUNG RETRACTORS: DAVIDSON, SEMB | February 10, 1994 |
| K926585 | t. korossurgical instruments | THOROCOSCOPY SELF-RETAINING RETRACTOR | August 6, 1993 |
| K921017 | medin | HARGIS SR2 SELF-RETRACTION SYSTEM | July 2, 1993 |
| K921020 | medin | HARGIS SELF RETRACTION SYSTEM | July 2, 1993 |
| K921019 | medin | HARGIS RECTAL SELF RETRATION SYSTEM | July 2, 1993 |
| K922626 | andronic devices | ADEPT INSTRUMENT POSITIONING ACCESSORY | October 19, 1992 |
| K922625 | andronic devices | ADEPT ENDOSCOPIC POSITIONER | October 19, 1992 |
| K920471 | lifeguard medical products | LEVY ARTICULATING RETRACTOR | June 23, 1992 |