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#
- 8043622
- 3013546462
- 2125050
- 3006561161
- 3034688516
- 3010047454
- 1222773
- 9611503
- 3006639944
- 1226544
- 2648727
- 3002806535
- 3003687489
- 3012995405
- 3014662844
- 3003587896
- 3009468807
- 3008843439
- 3001297506
- 3010611926
- 3006169466
- 1221934
- 3005528784
- 9615005
- 3004705187
- 3008338766
- 9614062
- 3035678069
- 3012447612
- 2248030
- 3019878714
- 3002808022
- 3005031160
- 2528981
- 3007289408
- 3012104767
- 3015895045
- 3008618183
- 3013055499
- 3008500478
- 3008593890
- 3011452218
- 3008280196
- 3013960851
- 3017565094
- 3038503932
- 3042235752
- 3018094310
- 3010386387
- 3002858762
- 1043214
- 3005853033
- 3002675176
- 3010455030
- 3038776593
- 9611262
- 1058020
- 3007441485
- 3010055973
- 3010370500
- 3010123206
- 8043496
- 3008992889
- 3010726901
- 3015167917
- 9614986
- 9611616
- 3043521642
- 3042244574
- 2084346
- 3040265659
- 3006946279
- 1224360
- 3010370554
- 3004142400
- 3014110984
- 3012966183
- 3004111573
- 2529846
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