FDA Product Code
FDA Product Code GCY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4680
510(k) Clearances — 96 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972703 | REDYROB-CLOSED WOUND DRAINAGE SYSTEM | B.Braun Medical, Inc. | 1997-10-01 | Traditional | PDF ↗ |
| K971036 | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | Interpore Intl. | 1997-06-03 | Traditional | PDF ↗ |
| K963839 | CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 | Cordis Corp. | 1996-12-12 | Traditional | PDF ↗ |
| K960099 | PENROSE DRAIN MODELS 6001 - 6007 | Sil-Med Corp. | 1996-03-11 | Traditional | PDF ↗ |
| K950754 | MACRO SUCTION TUBE MODEL NO 10061 | Dlp, Inc. | 1995-04-25 | Traditional | PDF ↗ |
| K936223 | PRESSURE IRRIGATING SYSTEM | Level 1 Technologies, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K930615 | AUTOVAC CLOSED WOUND SUCTION SYSTEM | Boehringer Laboratories | 1994-02-22 | Traditional | PDF ↗ |
| K933319 | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM | Birtcher Medical Systems, Inc. | 1993-10-27 | Traditional | PDF ↗ |
| K933305 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE | Inman Medical Corp. | 1993-10-05 | Traditional | PDF ↗ |
| K933306 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES | Inman Medical Corp. | 1993-10-05 | Traditional | PDF ↗ |
| K933170 | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT | Inman Medical Corp. | 1993-09-16 | Traditional | PDF ↗ |
| K931950 | POOLE TIP SUCTION PROBE | Mayaguez Medical Center | 1993-08-11 | Traditional | PDF ↗ |
| K931856 | 5.0 MM IRRIGATION/ASPIRATION PROBE | Mayaguez Medical Center | 1993-08-10 | Traditional | PDF ↗ |
| K925024 | ORC TAPPERED IRRIGATING PROBE | O.R. Concepts, Inc. | 1993-05-21 | Traditional | PDF ↗ |
| K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | 1993-05-17 | Traditional | PDF ↗ |
| K920819 | ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN | Astra Meditec AB | 1993-03-24 | Traditional | PDF ↗ |
| K925989 | KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-02-26 | Traditional | PDF ↗ |
| K925749 | KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-02-01 | Traditional | PDF ↗ |
| K922895 | J-VAC BULB SUCTION RESERVOIR | Johnson & Johnson Medical, Inc. | 1992-09-15 | Traditional | PDF ↗ |
| K915867 | SOLCOVAC WOUND DRAINAGE SYSTEM | Solco Basle, Inc. | 1992-08-14 | Traditional | PDF ↗ |
| K915536 | DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC | Davol, Inc. | 1992-03-26 | Traditional | PDF ↗ |
| K910167 | MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM | Microbio-Medics, Inc. | 1991-04-15 | Traditional | PDF ↗ |
| K905733 | SEROMA-CATH CLOSE DRAINAGE SYSTEM | Dawn Medical | 1991-01-28 | Traditional | PDF ↗ |
| K901764 | INAMED CONVERTIBLE DRAIN SYSTEM | Inamed Development Co. | 1990-05-07 | Traditional | PDF ↗ |
| K901742 | INAMED SMALL DRAIN SYSTEM | Inamed Development Co. | 1990-05-07 | Traditional | PDF ↗ |
| K896491 | INAMED CLOSED-WOUND DRAIN SYSTEM | Inamed Development Co. | 1990-01-08 | Traditional | PDF ↗ |
| K896803 | CLOSED WOUND RESERVOIR | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 | Traditional | PDF ↗ |
| K883982 | DRENOVAC | Iberhospitex, S.A. | 1989-02-23 | Traditional | PDF ↗ |
| K883472 | CLOSED WOUND SUCTION DEVICE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1988-10-18 | Traditional | PDF ↗ |
| K883433 | AMBU TWIN PUMP - (MANUAL SUCTION PUMP) | Ambu, Inc. | 1988-09-02 | Traditional | PDF ↗ |
| K881036 | HEMO SUC NUMBER HS100-HS205 | Instrumental Medico Croquevielle S.A. | 1988-06-20 | Traditional | PDF ↗ |
| K881012 | WOUND-EVAC RS | Heritage Medical Products | 1988-03-17 | Traditional | PDF ↗ |
| K880650 | HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS | Baxter Healthcare Corp | 1988-02-24 | Traditional | PDF ↗ |
| K874645 | CLOSED WOUND DRAINAGE SYSTEMS | Hall Laboratories, Inc. | 1987-12-02 | Traditional | PDF ↗ |
| K873332 | MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM | American V. Mueller | 1987-09-08 | Traditional | PDF ↗ |
| K863482 | DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE | Cardio Metrics, Inc. | 1986-10-14 | Traditional | PDF ↗ |
| K863562 | URESIL 150CC BELLOWS RESERVOIR | Uresil Corp. | 1986-09-29 | Traditional | PDF ↗ |
| K863505 | URESIL CLOSED DRAINAGE RESERVOIR | Uresil Corp. | 1986-09-18 | Traditional | PDF ↗ |
| K863201 | NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC | Allergan, Inc. | 1986-08-29 | Traditional | PDF ↗ |
| K860981 | ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM | Sun Technologies | 1986-05-02 | Traditional | PDF ↗ |
| K854424 | BARD PARKER 150CC BELLOWS RESERVOIR | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-11-20 | Traditional | PDF ↗ |
| K853295 | EMODREN EXCHANGEABLE PLASTIC BELLOWS | Parexel Intl. Corp. | 1985-08-20 | Traditional | PDF ↗ |
| K850634 | SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS | Surgidyne, Inc. | 1985-06-28 | Traditional | PDF ↗ |
| K851084 | ECONOMY 400 CWS WITH PVC DRAINS | C.R. Bard, Inc. | 1985-06-04 | Traditional | PDF ↗ |
| K850011 | PROVAC WOUND HEALING/SUCTION SET | Medical Matrix, Inc. | 1985-05-21 | Traditional | PDF ↗ |
| K850037 | CLOSED WOUND DRAIN | Consolidated Medical Equipment, Inc. | 1985-03-19 | Traditional | PDF ↗ |
| K844921 | PERIMETER CLOSED WOUND RESEVOIR | Perimeter Medical, Inc. | 1985-03-18 | Traditional | PDF ↗ |
| K842710 | CONCEPT C-VAC | Concept, Inc. | 1984-10-31 | Traditional | PDF ↗ |
| K840913 | PROVAC WOUND DRAINAGE & HEALING SYS | Meyer Medical U.S.A., Inc. | 1984-04-24 | Traditional | PDF ↗ |
| K833586 | TLS BULB DRAINAGE SYSTEM | Porex Medical | 1984-01-30 | Traditional | PDF ↗ |
| K830123 | DISP. YANKAVER SURG. SUCTION INSTRUMENT | Narco Scientific | 1983-06-08 | Traditional | PDF ↗ |
| K830607 | SUCTION RESERVOIR | Sil-Med Corp. | 1983-05-02 | Traditional | PDF ↗ |
| K830510 | BBL STREP GROUPING KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-05-02 | Traditional | PDF ↗ |
| K823284 | STRYKER CONSTAVAC | Stryker Corp. | 1983-01-14 | Traditional | PDF ↗ |
| K822902 | MINI-VAC DRAIN SYSTEM | Angus Medical Co. | 1982-12-28 | Traditional | PDF ↗ |
| K822032 | LARGE VOLUME CLOSED WOUND SUCTION DRAIN | American Heyer Schulte | 1982-08-16 | Traditional | PDF ↗ |
| K821563 | ARGYLE VAC-U-CARE 100CC SUCTION RESERV | Sherwood Medical Co. | 1982-06-21 | Traditional | PDF ↗ |
| K820474 | P-S SUCTION RESERVIOR | Pudenz-Schulte Medical Research Corp. | 1982-03-08 | Traditional | PDF ↗ |
| K813377 | PS-ROUND SURG. DRAIN & CONNECTOR | Pudenz-Schulte Medical Research Corp. | 1982-01-05 | Traditional | PDF ↗ |
| K813341 | WOUND-EVAC | Heritage Medical Products | 1981-12-18 | Traditional | PDF ↗ |
| K811557 | DEPUY HEMODRAIN | Depuy, Inc. | 1981-07-20 | Traditional | PDF ↗ |
| K811203 | SAF SINGLE-USE AEROSOL FILTER | Sorensen Research | 1981-05-21 | Traditional | PDF ↗ |
| K810636 | VARIODRAIN | Colmed, Ltd. | 1981-05-01 | Traditional | PDF ↗ |
| K810416 | SARNS MINI-SUCKER | 3M Health Care, Sarns | 1981-03-05 | Traditional | PDF ↗ |
| K802973 | ISPVAC TM | Innovative Surgical Products, Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K802214 | COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM | Cox-Uphuff Intl. | 1980-10-23 | Traditional | PDF ↗ |
| K801766 | JACKSON-PRATT LARGE VOL. CLOSED WOUND | American Heyer Schulte | 1980-08-20 | Traditional | PDF ↗ |
| K801612 | FRAZIER-FERGUSON SUCTION TUBES (DISP.) | Edward Weck, Inc. | 1980-08-04 | Traditional | PDF ↗ |
| K801350 | ACUVAC(TM) SUCTION RESERVOIR 400CC AND | Innovative Surgical Products, Inc. | 1980-07-14 | Traditional | PDF ↗ |
| K801442 | P-S SURGICAL DRAIN | Pudenz-Schulte Medical Research Corp. | 1980-07-14 | Traditional | PDF ↗ |
| K801443 | P-S SUCTION RESERVOIR | Pudenz-Schulte Medical Research Corp. | 1980-07-14 | Traditional | PDF ↗ |
| K801372 | ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR | Sherwood Medical Co. | 1980-06-26 | Traditional | PDF ↗ |
| K801371 | ARGYLE VAC-U-CARE FLAT SILICONE WOUND T. | Sherwood Medical Co. | 1980-06-26 | Traditional | PDF ↗ |
| K800578 | SURGIVAC TM | Snyder Laboratories, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K800543 | SNYDER HYSTERECTOMY Y TUBE KIT | Snyder Laboratories, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K800577 | SNYDER HEMOVAC TM VENTED WOUND KIT | Snyder Laboratories, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K800581 | TLS TM SURGICAL DRAINAGE SYSTEM | Glasrock Products, Inc. | 1980-04-04 | Traditional | PDF ↗ |
| K800542 | 100 ML SNYDER HEMOVAC | Snyder Laboratories, Inc. | 1980-04-02 | Traditional | PDF ↗ |
| K800331 | SURGITEK FOERSTER FACE LIFT DRAIN | Medical Engineering Corp. | 1980-03-05 | Traditional | PDF ↗ |
| K800081 | DAVOL/ABAMSON SILICONE SUMP DRAIN | Davol, Inc. | 1980-01-28 | Traditional | PDF ↗ |
| K800014 | DOW CORNING/W RIGHT WOUND DRAINAGE SYS | Dow Corning Corp. Healthcare Industries Materials | 1980-01-17 | Traditional | PDF ↗ |
| K790654 | CLOSED WOUND VACUUM DRAINAGE SYSTEM | 3M Company | 1979-04-26 | Traditional | PDF ↗ |
| K790763 | MAXI-VAC TM | Med General | 1979-04-23 | Traditional | PDF ↗ |
| K782115 | ASTRA-VAC | Ab Astra | 1979-02-01 | Traditional | PDF ↗ |
| K782028 | ROUND SILICONE DRAIN | Davol, Inc. | 1978-12-20 | Traditional | PDF ↗ |
| K782026 | FLAT SILICONE DRAIN | Davol, Inc. | 1978-12-12 | Traditional | PDF ↗ |
| K781400 | HEMOVAC TUBING MATERIAL CHANGE | Snyder Laboratories, Inc. | 1978-09-20 | Traditional | PDF ↗ |
| K780848 | PORTABLE CLOSED WOUND SUCTION EVACUATOR | Biomet, Inc. | 1978-08-23 | Traditional | PDF ↗ |
| K771015 | VYGON RED-O-PACK | Coastal Bend Medical Products, Inc. | 1977-07-11 | Traditional | PDF ↗ |
| K760778 | T-TUBE DRAIN, ROUND | Heyer Schulte Corp. | 1976-11-03 | Traditional | PDF ↗ |
| K760700 | SILASTIC BRAND G7-2090A | Dow Corning Corp. Healthcare Industries Materials | 1976-11-02 | Traditional | PDF ↗ |
| K760601 | ARGYLE SUCTION CONTROL KIT | Sherwood Medical Co. | 1976-11-01 | Traditional | PDF ↗ |
| K760746 | YASARGIL SUCTION TUBE - LARGE | Codman & Shurtleff, Inc. | 1976-11-01 | Traditional | PDF ↗ |
| K760747 | YASARGIL SUCTION TUBE - MEDIUM | Codman & Shurtleff, Inc. | 1976-11-01 | Traditional | PDF ↗ |
| K760745 | YASARGIL SUCTION TUBE - SMALL | Codman & Shurtleff, Inc. | 1976-11-01 | Traditional | PDF ↗ |
| K760257 | SPONGE, RICHARDS WOUND DRAINAGE SYSTEM | Richard'S Medical Equip., Inc. | 1976-08-09 | Traditional | PDF ↗ |
Product code GCY · Class I · General, Plastic Surgery. Data: openFDA.