510(k) K980588
- Device
- CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
- Applicant
- CLARUS MEDICAL SYSTEMS, INC.
- 510(k) number
- K980588
- Product code
- GAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-08-18
- Date received
- 1998-02-17
- Regulation
- 878.4800
- Classification name
- Retractor
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE SAPPENFIELD
- Address
- 1000 Boone Ave. N. #100 Minneapolis MN US 55427 55427
FDA Registration Numbers#
- 8010379
- 3007307589
- 3014967149
- 2133687
- 1723241
- 8010433
- 3004464325
- 3017155536
- 3013055499
- 3007125392
- 3010097171
- 3005827567
- 3005273623
- 3013358456
- 3007366790
- 9612086
- 3011499367
- 8010099
- 3004638532
- 3010370554
- 3022747125
- 1833053
- 1221934
- 3004168759
- 3021519357
- 1835998
- 3011024991
- 3010386387
- 3009887475
- 3010235355
- 3009714701
- 3003587896
- 3007441485
- 9610809
- 3042508254
- 9612075
- 2133928
- 3030861184
- 3009882675
- 3003431869
- 3008747271
- 1043534
- 3007840839
- 3006128100
- 8043496
- 8010405
- 3009590742
- 9614093
- 3012507533
- 3037407500
- 1928237
- 3009189869
- 3008770252
- 1056350
- 3005677016
- 3008650117
- 9611813
- 3014725904
- 9611610
- 8010273
- 3002858762
- 3007789561
- 3005751028
- 2528981
- 3005180920
- 1522875
- 3026133770
- 3005031160
- 3001297506
- 3010611926
- 3004788213
- 1223656
- 3009962553
- 9611390
- 9616944
- 8010944
- 3010057495
- 8010697
- 3009255580
Source Documents#
Other 510(k) Records For Product Code GAD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152538 | JRP Wound Spreader | J.R. Parker, LLC | 2016-04-13 |
| K151104 | OTELO LL | Spineart | 2016-01-06 |
| K132645 | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | Medtronic, Inc. | 2013-10-04 |
| K071775 | DASH | Ezsurgical | 2007-08-07 |
| K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | Apple Medical Corp. | 2005-04-26 |
| K043602 | QUADRANT RETRACTOR SYSTEM | Medtronic Sofamor Danek | 2005-02-23 |
| K001339 | MRI FASTSYSTEM RETRACTOR SYSTEM | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 |
| K963006 | SCION SAPHENOUS VEIN HARVESTING SYSTEM | Scion International, Inc. | 1996-09-20 |
| K943875 | VILLALTA RETRACTOR | Hct, Inc. | 1994-11-09 |
| K942002 | RETRACTOR | Automated Medical Products Corp. | 1994-05-17 |
| K941448 | RETRACTOR | Technovations | 1994-04-15 |
| K930316 | LUNG RETRACTORS: DAVIDSON, SEMB | Thomasville Medical Assoc. | 1994-02-10 |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | 1993-08-06 |
| K921017 | HARGIS SR2 SELF-RETRACTION SYSTEM | Medin Corp. | 1993-07-02 |
| K921019 | HARGIS RECTAL SELF RETRATION SYSTEM | Medin Corp. | 1993-07-02 |
Legacy Summary#
summary
FDA Review#
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