510(k) K820377
- Device
- PILLING IDENTI-LOOPS
- Applicant
- NARCO SCIENTIFIC
- 510(k) number
- K820377
- Product code
- GAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-03-10
- Date received
- 1982-02-09
- Regulation
- 878.4800
- Classification name
- Retractor
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010667733
- 3008388260
- 1221934
- 3005528784
- 9610905
- 3025603301
- 3003882387
- 8043404
- 9611274
- 3009996260
- 1320468
- 2245304
- 3008843439
- 1315756
- 3005595283
- 1833506
- 3004983210
- 3001084743
- 3008936260
- 3021985829
- 3010370554
- 3003860739
- 9611112
- 3021666757
- 1051526
- 9617297
- 9680519
- 2529846
- 3004024955
- 1420054
- 3011452218
- 1923569
- 2087382
- 3015972753
- 3005977121
- 2080222
- 3009499159
- 1833053
- 9610612
- 3042244574
- 1522875
- 9680002
- 9680304
- 3031564283
- 3016112537
- 3001620590
- 3015167917
- 3015882686
- 3042255021
- 2030598
- 3006639944
- 8010300
- 3011137372
- 3010611926
- 3006561161
- 1055236
- 1000517406
- 3003687489
- 3012755988
- 3003407244
- 3022747125
- 3007307589
- 3004552850
- 3003860763
- 1649390
- 3008998256
- 3017410889
- 3009380063
- 3009590742
- 3014003062
- 1643264
- 3010399422
- 3015259876
- 3010071016
- 3013546462
- 3006179046
- 3013893019
- 2647580
- 3010047454
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Clarus Medical Systems, Inc. | 1998-08-18 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases