510(k) K830123
- Device
- DISP. YANKAVER SURG. SUCTION INSTRUMENT
- Applicant
- NARCO SCIENTIFIC
- 510(k) number
- K830123
- Product code
- GCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-08
- Date received
- 1983-01-11
- Regulation
- 878.4680
- Classification name
- Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- 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#
- 3008191511
- 9617601
- 9611590
- 3014342658
- 3006581122
- 3021970868
- 9611274
- 3008887731
- 1123137
- 3009494725
- 3017385563
- 3012711663
- 3013058659
- 3009104075
- 3010626066
- 3016159368
- 2030624
- 3011209790
- 1820334
- 2184009
- 3010757045
- 3003887292
- 8010939
- 2028175
- 1423537
- 3026630
- 3006610790
- 3021244152
- 3014421917
- 1043214
- 3014827316
- 1222928
- 2650143
- 9613910
- 3000247987
- 3005176727
- 1219659
- 3018762668
- 1424785
- 9680411
- 3008489813
- 3014637079
- 9610612
- 3016674858
- 9710567
- 3008264111
- 3013909820
- 3015495690
- 3012316249
- 3009889060
- 3013496867
- 1320894
- 1643817
- 3017618673
- 2244478
- 3009888344
- 2640138
- 3011137372
- 3003399181
- 9681848
- 3010419931
- 1055236
- 1623486
- 3005206084
- 1818910
- 2648727
- 2084346
- 3007329020
- 1416980
- 3011743372
- 1019003
- 3016426851
- 3007123908
- 9616991
- 3041276591
- 3027847726
- 2183744
- 3030447506
- 3015276780
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972703 | REDYROB-CLOSED WOUND DRAINAGE SYSTEM | B.Braun Medical, Inc. | 1997-10-01 |
| K971036 | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | Interpore Intl. | 1997-06-03 |
| K963839 | CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 | Cordis Corp. | 1996-12-12 |
| K960099 | PENROSE DRAIN MODELS 6001 - 6007 | Sil-Med Corp. | 1996-03-11 |
| K950754 | MACRO SUCTION TUBE MODEL NO 10061 | Dlp, Inc. | 1995-04-25 |
| K936223 | PRESSURE IRRIGATING SYSTEM | Level 1 Technologies, Inc. | 1994-05-12 |
| K930615 | AUTOVAC CLOSED WOUND SUCTION SYSTEM | Boehringer Laboratories | 1994-02-22 |
| K933319 | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM | Birtcher Medical Systems, Inc. | 1993-10-27 |
| K933305 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE | Inman Medical Corp. | 1993-10-05 |
| K933306 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES | Inman Medical Corp. | 1993-10-05 |
| K933170 | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT | Inman Medical Corp. | 1993-09-16 |
| K931950 | POOLE TIP SUCTION PROBE | Mayaguez Medical Center | 1993-08-11 |
| K931856 | 5.0 MM IRRIGATION/ASPIRATION PROBE | Mayaguez Medical Center | 1993-08-10 |
| K925024 | ORC TAPPERED IRRIGATING PROBE | O.R. Concepts, Inc. | 1993-05-21 |
| K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | 1993-05-17 |
Legacy Summary#
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FDA Review#
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