510(k) K800578
- Device
- SURGIVAC TM
- Applicant
- SNYDER LABORATORIES, INC.
- 510(k) number
- K800578
- Product code
- GCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-04-16
- Date received
- 1980-03-14
- 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#
- 9611590
- 8030107
- 3002808270
- 3014827316
- 3010626066
- 3008711096
- 3020306752
- 3009889060
- 3027847726
- 3003418325
- 1314417
- 3017540705
- 2110540
- 8043323
- 9616088
- 3013517171
- 3010198939
- 1034117
- 3033435481
- 9617601
- 9614062
- 3010325720
- 3009104075
- 1818910
- 2648727
- 3015219237
- 3005327291
- 2027062
- 8010939
- 3006581122
- 3013058659
- 3014342658
- 1043214
- 8022978
- 3033011342
- 1018470
- 3007123908
- 1019003
- 2084346
- 1061771
- 3008285983
- 3009888344
- 3017618673
- 3010806410
- 3012568936
- 3006673317
- 3006210673
- 3010400865
- 3018762668
- 9612030
- 2528981
- 1423537
- 3016248634
- 2184009
- 3007360714
- 3007007790
- 1623486
- 3011554160
- 3009134882
- 2916714
- 2011171
- 3012314549
- 3010834934
- 3003955307
- 3003965134
- 3013545943
- 3006446479
- 8010177
- 3003627840
- 9680411
- 1054241
- 2020550
- 9681848
- 3018116884
- 1320894
- 1643817
- 3007728072
- 3012711663
- 3006897996
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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